[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Georgetown University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":649},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,42,67,92,129,162,185,216,244,268,292,315,335,360,381,404,430,450,473,505,532,554,581,603,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100642076","phase-2-risk-adapt-protocol-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-100642076",false,"NCT07645326","RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)","A Pragmatic Phase 2 Trial of Risk-Adapted Treatment Approaches Including Treatment De-escalation to Minimize Adverse Effects of Hormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.","RISK-ADAPT","Inclusion Criteria:\n\n1. Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician.\n\n   a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment with ADT or ARPI for up to 8 weeks for mCSPC is permitted; however, prior treatment with docetaxel is not allowed.\n\n   b. High risk SOC: ADT + ARPI +\u002F- docetaxel i. For patients with high-risk disease (defined in Section 8.1), prior treatment with ADT, ARPI, or docetaxel for up to 8 weeks for mCSPC is permitted.\n2. Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans.\n\nExclusion Criteria:\n\n1. Patients for whom, in the opinion of the investigator, participation in the study, use of the drugs outlined in the study, or use of the risk-adapted treatment de-escalation strategy is not appropriate or safe.\n2. Patients who have received prior treatment with any of the following:\n\n   1. Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment;\n   2. Radiopharmaceuticals for prostate cancer any time prior to enrollment.\n3. Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment.\n4. Patients with prior treatment with an ARPI for non-metastatic disease within 6 months of diagnosis of metastatic disease are not eligible.\n\n   a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible.\n5. Patients who had previous (within 28 days before the start of study drug or 4 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).\n6. Patients with an inability to swallow oral medications in the opinion of the clinical investigator.\n7. Patients with leptomeningeal disease.","MALE","18 Years",{"count":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by treatment de-escalation at the Medstar Health network. A pragmatic design will be implemented in order to make the study available to patients at greatest needs from minority populations in the community. Additional assessments include quality-of-life (QoL) and sexual function changes as well as correlative studies. A maximum of 108 patients will be enrolled in this study. The investigators hypothesize that with a risk-adapted treatment approach followed by treatment de-escalation, more than 50% of patients will have radiographic progression-free survival (rPFS) at 36 months. Additionally, the investigators hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.",[28],"Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","NOT_YET_RECRUITING","2026-06-15",{"date":32,"type":33},"2026-06-17","ACTUAL",{"date":35,"type":22},"2026-08",{"date":37,"type":22},"2032-08",{"name":39,"class":40},"Georgetown University","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100642245","phase-2-mri-based-focal-intraprostatic-simultaneous-integrated-boost-sib-intensification-with-de-escalated-adaptive-risk-sbrt-for-patients-with-low-to-intermediate-risk-prostate-cancer-100642245","NCT07644598","MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer","A Phase II Study of MRI-based Focal Intraprostatic SIB (Simultaneous Integrated Boost) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer","MIDAS","Inclusion Criteria:\n\n1. Patients age 18 or older.\n2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n3. Patients with histologically confirmed adenocarcinoma of the prostate who have not received prior pelvic radiation therapy or prostatectomy.\n4. Patients with low to intermediate risk group defined by the NCCN (National Comprehensive Cancer Network) guidelines as follows:\n\n   * Low risk prostate cancer:\n\n     * cT1-cT2a (AJCC; 8TH edition, 2017)\n     * Grade Group 1 (GG1)\n     * PSA \\\u003C10 ng\u002FmL\n   * Intermediate risk prostate cancer:\n\n     * cT2b-cT2c (AJCC; 8TH edition, 2017)\n     * Grade Group 2 (GG2) or Grade Group 3 (GG3)\n     * PSA 10-20 ng\u002FmL\n5. Patients with unfavorable intermediate risk prostate cancer defined by the NCCN guidelines are recommended to undergo a PSMA (Prostate-Specific Membrane Antigen) PET, then the PSMA PET must show localized disease.\n6. Patients must have preferably undergone a standard of care pretreatment MRI fusion biopsy\\* to identify visible intraprostatic lesions and confirm the absence of regional or distant metastatic disease, with criteria as follows:\n\n   * Ability to undergo an MRI fusion biopsy;\n   * Prostate size \\\u003C100 cc on any diagnostic MRI;\n   * Presence of a visible prostatic lesion:\n\n     * PIRADS (Prostate Imaging-Reporting and Data System) 4+ lesion, and\u002For\n     * PIRADS 3 lesion with evidence of grade group 2-3\n   * Less than or equal to 4 lesions in total allowed;\n   * Lesion may contact the capsular edge, \"possible\" extracapsular extension (ECE) permitted; \\*MRI fusion biopsy is preferred but if the positive core is in the same region as the target on the MRI based on a systemic biopsy, the patient can be included.\n7. Genitourinary function with a baseline score ≤20 as defined by any pre-treatment IPSS questionnaire.\n8. Patients are mandated to get a fiducial placement. Optional proper rectal spacer placement is recommended as determined by the treating radiation oncologist based upon whether there is overt rectal wall invasion from the hydrogel spacer or if there is minimal to no separation of the prostate-rectal interface measured at the prostate mid-gland.\n9. Patients with a life expectancy of greater than 5 years as assessment by the investigator. Life expectancy can be estimated using any 1 of the following tools:\n\n   * The Social Security Administration tables: https:\u002F\u002Fwww.ssa.gov\u002FOACT\u002FSTATS\u002Ftable4c6.html\n   * The WHO's Life Tables by country: https:\u002F\u002Fapps.who.int\u002Fgho\u002Fdata\u002Fview.main.60000?lang=en\n   * The Memorial Sloan Kettering Male Life Expectancy tool: https:\u002F\u002Fwww.mskcc.org\u002Fnomograms\u002Fprostate\n   * If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.\n10. Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method, which together result in a failure rate of \\\u003C 1% per year, during the treatment period and for 1 year after treatment per local and institutional guidelines. Men must refrain from donating sperm during this same period.\n    * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period per local and institutional guidelines to avoid potential exposure to the embryo.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.\n11. Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n1. Patients with evidence of disease Grade Group 4 (GG4) or higher.\n2. Patients with PSA \\>20 ng\u002FmL.\n3. Patients with evidence of clinical stage T3a+ or gross extracapsular extension on the diagnostic MRI.\n4. Patients who received prior or concurrent androgen deprivation therapy for prostate cancer.\n5. Patients with more than 4 disease foci identifiable on MRI.\n6. Patients with evidence of metastatic disease on imaging (e.g., bone scan, PSMA PET scan, or MRI\u002FCT scan).\n7. Patients with ineligibility to undergo an MRI due to:\n\n   * The presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MRI unsafe;\n   * Severe claustrophobia;\n   * Inability to lie flat for the duration of the study;\n   * Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MRI;\n   * Any other reason as determined by the investigator or treating physician.\n8. Patients with an I-PSS score \\>20 as defined by any pre-treatment IPSS questionnaire.\n9. Patients with a prior history of transurethral resection of the prostate, TURP, Urolift, or other similar trans-urethral LUTS management procedure within the last 6 months.\n10. Patients with a prior history of severe urethral stricture.\n11. Patients with a prior history of pelvic irradiation.\n12. Patients unable to meet dosimetric constraints\n13. Patients with a prior history of non-cutaneous solid malignancy within the last 5 years.\n14. Patients with a history of active and uncontrolled inflammatory bowel disease.\n15. Patients who are unable to comply with follow-up visits and treatment plans.",{"count":51,"type":22},58,[25],"The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.",[55,56],"Prostate Cancer","Localized Prostate Carcinoma",[58],"Localized prostate cancer","2026-06-08",{"date":61,"type":33},"2026-06-12",{"date":63,"type":22},"2026-09",{"date":65,"type":22},"2035-01",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100550610","phase-2-neoadjuvant-chemo-immunotherapy-and-surgical-resection-in-locally-advanced-non-small-cell-lung-cancer-with-n3-lymph-node-involvement-100550610","NCT06449313","Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement","A Phase 2 Single-Arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer (NSCLC) With N3 Lymph Node Involvement","NEO-SURG","Inclusion Criteria:\n\n1. Age ≥ 18 years at time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed stage 3 B\u002FC Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC) with pathologically-confirmed contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement.\n3. Primary tumor appropriate for resection with curative intent as assessed by the treating surgeon prior to study enrollment.\n4. Absence of major associated pathologies and co-morbidities that elevate surgery risk to a prohibitive level, as assessed by treating surgeon prior to study enrollment.\n5. Pulmonary function capacity capable of tolerating the lung resection proposed by the treating surgeon.\n6. EGFR, ALK, wild-type assessed via any CLIA-certified tissue testing platform. Documentation of EGFR and ALK status is not required for pure squamous NSCLC histology.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 21 days prior to initiation of study treatment:\n\n   1. Absolute Neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (1000\u002FuL) without granulocyte colony-stimulating factor support\n   2. Platelet count ≥ 100 x 10\\^9\u002FL (100,000\u002FuL) without transfusion\n   3. Hemoglobin ≥ 90 g\u002FL (9.0 g\u002FdL) (Patients may be transfused to meet this criterion.)\n   4. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C\u002F= 3 x upper limit of normal (ULN)\n   5. Serum bilirubin \\\u003C\u002F= 2.0 x ULN with the following exception: Patients with known Gilbert disease: serum bilirubin \\\u003C\u002F= 3 x ULN\n   6. Creatinine clearance ≥ 45 mL\u002Fmin (calculated using the Cockcroft-Gault formula). If creatinine clearance determined by Cockcroft-Gault is \\\u003C45 mL\u002Fmin, another appropriate validated formula or 24hr urine collection may be used in consultation with the study PI.\n   7. For patients not receiving therapeutic anticoagulation: INR (international normalised ratio) and aPTT (activated partial thromboplastin time) \\\u003C\u002F= 1.5 x ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen defined as clinical stability on unchanged dose of therapeutic anticoagulation for ≥14 days.\n9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n   Women must remain abstinent or use highly effective contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 4 months after the final dose of study treatment. Women must refrain from donating eggs during this same period.\n\n   A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\n   Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n   The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n10. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\nWith a female partner of childbearing potential who is not pregnant, or a female partner who is pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 4 months after the final dose of study treatment. Men must refrain from donating sperm during this this same period.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\nExclusion Criteria:\n\n1. NSCLC with histology containing any of the following: large cell neuroendocrine carcinoma, small cell lung cancer.\n2. Primary tumor not deemed appropriate for surgical resection as assessed by treating surgeon.\n\n   1. Tumor with direct invasion of: mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina.\n   2. Any other tumor characteristic making it not suitable for resection as determined by treating surgeon.\n3. Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.\n4. History of malignancy requiring systemic therapy within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death as assessed and confirmed by the study PI. (Patients with a history of stage I NSCLC treated with resection or radiotherapy are eligible for inclusion.)\n5. Active or history of clinically significant autoimmune disease that, in the opinion of the investigator, could compromise the health and safety of the patient if treated with anti-PD1 immunotherapy. Notable exceptions include:\n\n   1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone.\n   2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen.\n   3. Active or history of adrenal insufficiency on stable steroid regimen.\n   4. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n6. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n7. Known active tuberculosis.\n8. Known history of poorly controlled HIV. Patients living with HIV are allowed to enroll if: (1) they are clinically stable on appropriate highly active anti-retroviral therapy (HAART) with undetectable HIV viral load and CD4 count \\>350 and (2) the HAART regimen poses no unacceptable interactions with the prescribed anti-cancer therapies.\n9. Known history of poorly controlled hepatitis B or hepatitis C\n\n   1. Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus (HBV) DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n   2. Patients who are known hepatitis C virus (HCV) antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n10. Severe infection within 3 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection (including COVID-19), bacteremia, or severe pneumonia that, in the opinion of the investigator, may impact patient safety.\n11. Prior allogeneic stem cell or solid organ transplantation.\n12. Any treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment.\n13. Significant vascular and cardiovascular disease (e.g., New York Heart Association Class II or greater heart failure, unstable arrhythmia, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis - including but not limited to myocardial infarction, transient ischemic attack, stroke or unstable angina) within 6 months prior to study treatment initiation.\n14. Treatment with systemic immunosuppressive medication (including, but not limited to: corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n    1. Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after PI confirmation has been obtained.\n    2. Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n15. Any prior use of an immune checkpoint blockade therapy including agents directed against CTLA-4, PD-1, and PD-L1.\n16. History of severe allergic reaction or hypersensitivity to study drug components.\n17. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.","ALL",{"count":77,"type":22},21,[25],"The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement..\n\nThe main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy.\n\nParticipants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.",[81],"Non-small Cell Lung Cancer Stage III",[83],"non-small cell lung cancer","RECRUITING",{"date":86,"type":33},"2026-06-10",{"date":35,"type":22},{"date":89,"type":22},"2032-09",{"name":39,"class":40},3,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":115,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100642991","home-based-vision-rehabilitation-guided-by-brain-imaging-100642991","NCT07635329","Home-based Vision Rehabilitation Guided by Brain Imaging","Behavioral Rehabilitation Through Image-Guided Home-based Training","BRIGHT","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Capable of providing informed consent and complying with study procedures.\n3. Unilateral or bilateral focal brain damage causing visual field loss.\n4. At least three months post-stroke or traumatic brain injury, or a stable brain tumor within the past year.\n5. Eligible for MRI based on standard safety screening.\n\nExclusion Criteria:\n\n1. Severe neurological or psychiatric conditions unrelated to the focal lesion that may interfere with study participation or data interpretation.\n2. Current or recent (within the past 6 months) drug or alcohol abuse or addiction as defined by DSM-5.\n3. Ocular disease or disorder.",{"count":101,"type":22},100,[103],"NA","The BRIGHT (Behavioral Rehabilitation Through Image-Guided Home-based Training) study aims to evaluate the effectiveness of image-guided, home-based perceptual training at improving visual performance in individuals with visual field loss.\n\nUsing a prospective, crossover design, BRIGHT combines visual behavioral testing, neuroimaging, and a home-based intervention. It aims to 1) identify neural pathways that support training-induced visual plasticity; and 2) compare the efficacy of different types of visual training delivered in a home-based setting.",[106,107,108,109,110,111,112,113,114],"Visual Field Defect","Stroke","Hemianopia Homonymous","Quadrantanopia","Cortical Blindness","Visual Field Defect, Peripheral","Visual Field Loss","Traumatic Brain Injury","Brain Tumor",[116,117,118,119,120],"neuroplasticity","stroke","vision","TBI","brain tumor","2026-06-03",{"date":123,"type":33},"2026-06-09",{"date":125,"type":22},"2026-07-01",{"date":127,"type":22},"2030-03-31",{"name":39,"class":40},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100637829","expanding-genetic-access-for-prostate-cancer-survivors-100637829","NCT07618520","Expanding Genetic Access for Prostate Cancer Survivors","Expanding Genetic Access and Guided Education for Prostate Cancer Survivors","ENGAGE","Inclusion Criteria:\n\n* 18-80 years of age\n* At least 6-months post diagnosis with prostate cancer\n* Have not had genetic testing for hereditary cancer\n* Have received care at one of the participating sites in the prior five years\n* Meet National Comprehensive Cancer Network criteria for germline GT\n* Able to read and speak in English\n* Capable of providing informed consent\n* Have internet access (via smartphone, tablet or computer)\n* Comfortable using a computer or mobile phone independently to access information\n\nExclusion Criteria:\n\n* Do not speak English\n* Unable to access the Internet\n* Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)\n* Are unable to provide informed consent","80 Years",{"count":139,"type":22},500,[103],"The goal of this study is to increase genetic education and genetic testing for hereditary cancer risk among prostate cancer survivors. The study will:\n\nTest the effectiveness of a digital guide (DG+) vs. print guide (Print+) vs. enhanced usual care (EUC) on engagement in genetic education and uptake of genetic testing.\n\nEvaluate the impact of the DG+ vs. Print+ vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes).\n\nExplore the ways (methods) that influence how participants experience the intervention.\n\nThe main questions this study aims to answer are: which group - the digital guide (DG+) group, print (Print+) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education.\n\nParticipants will be randomly assigned to either the digital guide (DG+) group, the print guide (Print+) group or EUC group. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the three groups to determine which is most most likely to complete genetic testing (GT) and which group engages more with genetic education.",[143,144,145],"Prostate Cancer Patients","Hereditary Cancer","Genetic Testing",[147,148,149,150,151,152],"Prostate cancer","survivorship","genetic counseling","genetic testing","hereditary cancer","Chatbot","2026-05-25",{"date":155,"type":33},"2026-06-01",{"date":157,"type":22},"2026-08-01",{"date":159,"type":22},"2030-07-31",{"name":39,"class":40},2,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":75,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100639686","phase-2-resveratrol-in-parkinsons-disease-reset-100639686","NCT07592767","RESvEraTrol in Parkinson's Disease (RESET)","Multicenter, Randomized, Double Blind, Placebo-Controlled Phase 2a Study, to Evaluate Safety, Tolerability and Pharmacokinetics of Resveratrol (JOTROLTM) in Parkinson's Disease","RESET","Inclusion Criteria:\n\n* Capable of providing informed consent (IC) and complying with study procedures\n* Stable on Levodopa and\u002For DA agonists for at least 4 weeks before enrollment\n* Clinical diagnosis of PD according to UK Brain Bank criteria and\u002For PD with Dementia (PDD) by MDS criteria (53-55).\n* MoCA≥18.\n* Hohn and Yahr stage 2 and 3\n* Age of 55-85 years, medically stable\n* English Fluency\n\nExclusion Criteria:\n\n* Known PD-linked gene mutations e.g. PINK-1, DJ-1, parkin, LRRK2 etc.\n* Clinical signs indicating syndromes or disorders other than PD including, Alzheimer's Disease (AD), corticobasal degeneration (CBD), supranuclear gaze palsy, multiple system atrophy (MSA), chronic traumatic encephalopathy (CTE), frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement\n* Any psychiatric diagnosis or symptoms, (e.g., hallucinations and suicidality, major depression, or delusions) that could interfere with study procedures\n* Medical history of liver or pancreatic disease, GI, ulcers and Chron's disease, kidney, or blood problems. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline. Any other medical conditions (e.g., cardiac, respiratory, GI, renal disease) which are not adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments and are below grade 3 criteria as outlined in table 2.\n* Enrolled as an active participant in another clinical study\n* Anti-coagulant medications, including Coumadin, heparin, enoxaparin, fondaparinux etc.\n* Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressant's, or plasmapheresis during the\n* Geriatric Depression Scale (GDS) score greater than or equal to 8 at Screening.\n* Answer \"yes\" to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.\n* Planned surgery which requires general anesthesia that would take place during the study.\n* Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.\n* Women of Childbearing Potential (WCBP) or lactating.\n* Must not be on any nutritional or medicinal supplements at least 6 weeks prior to enrollment.","55 Years","85 Years",{"count":173,"type":22},30,[25],"This is an exploratory phase 2a study to investigate two doses of resveratrol (JotrolTM) vs placebo in individuals diagnosed with Parkinson's Disease (PD). Participants (n=30) will be randomized 1:1:1 into 3 groups and will receive oral JotrolTM vs placebo. Study drug will be titrated to reach a final maximal dose per group and will be administered orally once daily (QD) for 3 months. The study will primarily evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics (PK\u002FPD) of JotrolTM.",[177],"Parkinson's Disease","2026-05-11",{"date":180,"type":33},"2026-05-18",{"date":155,"type":22},{"date":183,"type":22},"2029-06-01",{"name":39,"class":40},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":191,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":203,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":161},"100610470","bundled-cancer-screening-and-genetic-services-navigation-100610470","NCT07228000","Bundled Cancer Screening and Genetic Services Navigation","Inclusion Criteria:\n\n1. Seeking screening navigation services through programs at a participating site (Georgetown Lombardi Cancer Center or Helen F. Graham Cancer Center \\& Research Institutes)\n2. Eligible for breast cancer screening while also due and eligible for colorectal cancer screening (per USPSTF guidelines)\n3. Female sex\n4. Aged 45-74\n5. Identify as Black\u002FAfrican American race and\u002For Hispanic\u002FLatin(e)(a) ethnicity\n6. Speak English or Spanish with enough fluency to complete study activities\n7. Stated willingness to comply with all study procedures (navigation, surveys) and availability for the duration of the study\n8. Provision of completed electronic informed consent form\n\nExclusion Criteria:\n\n1. Not engaged with or planning to use navigation programs at Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center \\& Research Institute\n2. Not eligible for breast cancer screening or not due and eligible for colorectal cancer screening (per USPSTF guidelines)\n3. History of breast and\u002For colorectal cancer; or Reporting symptoms related to breast and\u002For colorectal cancer (e.g., GI bleeding, breast mass)\n4. Male sex, Intersex, or other sex\n5. Under age 45 or over age 74\n6. Identifies as neither Black\u002FAfrican American race nor Hispanic\u002FLatin(e)(a) ethnicity\n7. Speaks neither English nor Spanish with enough fluency to complete study activities\n8. Stated unwillingness to comply with study procedures (navigation, surveys) or unavailability for the duration of the study\n9. Inability to provide electronic informed consent, or needing another person to authorize informed consent on their behalf",true,"FEMALE","45 Years","74 Years",{"count":196,"type":22},820,[103],"The goal of this study is to test bundled familial cancer risk assessment + multicancer (colorectal + breast) vs. single (breast) cancer navigation, using a wait list control for colorectal cancer screening referral and navigation. Among those eligible, this study will test usual care referral to genetic services vs. pretest education + usual care referral. The study also will assess how bundled multicancer navigation works and for whom it is most effective through a multisite, mixed-methods patient- and organization-level process evaluation.",[200,201,202],"Breast Cancer Screening","Colon Cancer Screening","Genetics Predisposition",[204,205,206,207,150,208],"navigation","mammography","colonoscopy","Fecal Immunochemical Test","risk assessment","2026-05-06",{"date":211,"type":33},"2026-05-08",{"date":209,"type":33},{"date":214,"type":22},"2029-05-31",{"name":39,"class":40},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":41},"100595112","mindful-self-compassion-for-anxiety-and-depression-impact-of-delivery-method-100595112","NCT07028216","Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method","Mindful Self-Compassion for Anxiety and Depression: A Randomized Comparison of In-Person Versus Videoconference Delivery","Inclusion Criteria:\n\n* Must have a primary anxiety disorder (social anxiety disorder, generalized anxiety disorder, panic disorder, or agoraphobia) or major depressive disorder, current\n* Must score low on self-compassion, as measured by the self-compassion scale\n* Must understand study procedure and willing to participate in all testing visits, and treatment as assigned\n* Must be able to give informed consent to the study procedures\n\nExclusion Criteria:\n\n* Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, obsessive compulsive disorder, eating disorders (i.e., anorexia and bulimia), bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders and current post-traumatic stress disorder as assessed by clinician at screening visit\n* A serious medical condition that may result in surgery or hospitalization.\n* A history of head trauma causing prolonged loss of consciousness, or ongoing cognitive impairment\n* Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview).\n* Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.\n* Subjects taking some psychiatric medication such as barbiturates or antipsychotics. Sleep medications and some anti-depressants will be allowed, if the subject has been taken at stable dose 8 weeks prior to baseline and the patient plans to continue at the same dose through the trial.\n* Concurrent psychotherapy initiated within 1 month of screen interview, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety (such as Cognitive Behavioral Therapy).\n* Individuals who have completed a course of MSC or an equivalent meditation training in the last year.\n* Individuals reporting significant active suicidal ideation or suicidal behaviors within the past year.\n* Individuals with a medical condition (i.e., epilepsy) that may be exacerbated by study treatment, as determined by a study physician or nurse practitioner based on history, physical, and\u002For labs.\n* Adults unable to consent\n* Pregnant women\n* Prisoners","65 Years",{"count":225,"type":22},80,[103],"The study will compare the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder or dysthymia.",[229,230,231,232,233,234,235],"Anxiety Disorders","Generalized Anxiety Disorder","Social Anxiety Disorder","Panic Disorder","Agoraphobia","Major Depressive Disorder","Persistent Depressive Disorder (Dysthymia)","2026-05-03",{"date":238,"type":33},"2026-05-05",{"date":240,"type":33},"2025-06-01",{"date":242,"type":22},"2027-08-31",{"name":39,"class":40},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":161},"100585458","treatment-de-escalation-for-favorable-prognosis-human-papilloma-virus-hpv-or-p16-positive-oropharyngeal-cancer-receiving-definitive-radiotherapy-100585458","NCT06902623","Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy","A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy","Lombardi197","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age on the day of signing informed consent.\n* Patients must have a diagnosis of p16+ and\u002For HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and\u002For posterior oropharyngeal wall).\n* clinical stage stage I-II (T1-2 N1 M0, or T3 N0-1 M0 ) (AJCC 8th ed.) SCCA of the oropharynx that would mandate definitive chemoradiation as current standard of care when standard radiation fractionation is applied. Debulking of the disease by resecting the exophytic portion of the tumor for biopsy\u002Fsample or symptom alleviation will be permitted, as long as gross unresected tumor is left behind.\n* Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment.\n* Patients must have Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration\n* Patients must have had a neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.\n* Patient must have had a hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.\n* Patients must be a current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients with gross involvement of level 4 lymph node level\n* Endophytic T3 disease, as clinically determined by the principal investigator.\n* Patients with any single lymph node \\> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \\>4cm is allowed)\n* Patients with nodal disease clinically fixed to or radiographically invading adjacent neck musculature any single lymph node \\> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \\>4cm is allowed)\n* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free, or Gleason 6 prostate cancer undergoing active surveillance.\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.",{"count":173,"type":22},[103],"The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.",[256,257,258,259],"Oropharyngeal Cancers","HPV","Tonsil Cancer","Base of Tongue Cancer","2026-04-14",{"date":262,"type":33},"2026-04-17",{"date":264,"type":33},"2019-08-01",{"date":266,"type":22},"2030-12-31",{"name":39,"class":40},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":191,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":41},"100558671","de-escalation-of-adjuvant-radiation-for-low-risk-hpv-oropharyngeal-cancers-100558671","NCT06554158","De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers","A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age on the day of signing informed consent.\n* Patients must have a diagnosis of p16+ and\u002For HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and\u002For posterior oropharyngeal wall).\n* pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.\n* Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.\n* neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.\n* hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.\n* current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history\n* start radiation within 8 weeks of resection (6 weeks preferable)\n* have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Perineural invasion at primary site\n* Lymphovascular space invasion at primary site\n* Level 4 nodal involvement (even if resected)\n* Retropharyngeal nodal involvement (even if resected)\n* any intact, unresected disease\n* nodal disease pathologically invading adjacent neck musculature\n* Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy\n* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.\n* Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma",{"count":173,"type":22},[103],"The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV\u002Fp16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are:\n\nDoes radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields?\n\nParticipants will:\n\nUndergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)",[279],"Oropharynx Cancer",[257,281,282,283,284],"tonsil","base of tongue","soft palate","oropharyngeal cancer","2026-03-19",{"date":287,"type":33},"2026-03-23",{"date":264,"type":33},{"date":290,"type":22},"2028-12-31",{"name":39,"class":40},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":91},"100438501","phase-1-phase-ibii-of-cpx-351-for-relapse-prevention-in-aml-100438501","NCT04990102","Phase IB\u002FII of CPX-351 for Relapse Prevention in AML","Phase IB\u002FII of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation","Inclusion Criteria:\n\n* Newly diagnosed patients \\> 18 years of age\n* Patients must be in CR or CRh (complete remission with partial count recovery).\n* Must have received ANY induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax, for up to 6 cycles or no more than 12 cycles of treatment.\n* Must be able to start therapy within 3 months of last documented CR\n* De novo or secondary AML\u002Ftreatment related AML (non-M3) including AML with myelodysplasia-related changes (MRC), histologically confirmed\n* Patients must be ineligible for allogeneic BMT (for any reason including poor performance status, patient's preference, favorable AML not a candidate for transplant, or comorbidities and age precluding from transplant etc)\n* Cardiac ejection fraction ≥ 50% by transthoracic echocardiography or MUGA scan\n* Adequate hepatic and renal function defined as:\n\n  * Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)\n  * Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 is permissible if due to disease.\n  * Bilirubin ≤3 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n  * Estimated Creatinine Clearance ≥30 ml\u002Fmin (Cockcroft-Gault based on actual weight) (See Appendix A)\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 (Appendix A)\n* Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.\n* Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices \\[IUDs\\], sexual abstinence, or sterilized partner) during the period of therapy and for at least 6 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Prior allogeneic transplant\n* Previous cumulative anthracycline (doxorubicin equivalent) dose equal to or greater than 345 mg\u002Fm2, and for patients with prior mediastinal XRT, anthracycline dose equal to or greater than 295 mg\u002Fm2\n* Acute promyelocytic leukemia \\[t(15;17)\\]\n* If patient is unable to sign informed consent due to any serious medical condition, laboratory abnormality or psychiatric illness\n* Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)\n* History of Wilson's disease or other copper-related disorders\n* History of allergic reactions attributed to compounds of similar composition to cytarabine and daunorubicin or liposomal products\n* History of other malignancies, except:\n\n  * Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated low risk prostate cancer or carcinoma in situ without evidence of disease.\n* Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), grade ≤1, or to the levels dictated in the inclusion\u002Fexclusion criteria with the exception of alopecia.\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* Known active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).\n* Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, must have a negative polymerase chain reaction (PCR) result for the respective disease before enrollment. Those who are PCR positive will be excluded.\n* Any uncontrolled active systemic infection.\n* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.\n* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.\n* Known CNS involvement by leukemia\n* Erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome\n* Lactating or pregnant.\n* Unwilling or unable to participate in all required study evaluations and procedures.\n* Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).\n* Currently active, clinically significant hepatic impairment (≥ moderate hepatic impairment according to the Child Pugh classification (class B or C))",{"count":300,"type":22},24,[302,25],"PHASE1","This is a phase IB\u002FII study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.",[305],"Acute Myeloid Leukemia (AML) in Remission",[307,308],"Acute Myeloid Leukemia","Remission",{"date":287,"type":33},{"date":311,"type":33},"2023-05-22",{"date":313,"type":22},"2026-12",{"name":39,"class":40},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":334,"locationsCount":161},"100476062","phase-2-a-combination-therapy-strategy-to-prevent-anti-pd-1-therapy-resistance-in-metastatic-ovarian-cancer-patients-100476062","NCT05479045","A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients","Inclusion Criteria:\n\n1. Be able and willing to provide written and signed informed consent prior to performing any protocol-related procedures, including screening evaluations.\n2. Women, 18 years or older, with stage III \u002F IV platinum-refractory Ovarian Cancer (OC) (progressed on a platinum containing regimen within 6 months of therapy and adenocarcinoma histology) that can be evaluable by RECISTv1.1 criteria who progressed on standard treatment. Participants will be recruited irrespective of if they earlier received available FDA-approved therapies (including for participants with targetable mutations, such as BRCA mutations)\n3. Subjects will be eligible for study entry based on the following diagnostic workup:\n\n   1. History\u002Fphysical examination within 28 days prior to registration.\n   2. Imaging of target lesion(s) within 28 days prior to registration.\n   3. Study-specific assessments:\n   4. Recovery from effects of recent surgery, radiotherapy or chemotherapy.\n   5. Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection).\n   6. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.\n   7. Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C).\n   8. Any prior radiation therapy must be completed at least 4 weeks prior to registration.\n   9. At least 4 weeks must have elapsed since major surgery.\n4. Subjects must have received and have progressed, are refractory, or are intolerant to standard platinum therapy. Subjects should not have received more than 2 prior lines of systemic therapy for recurrent or metastatic disease (including both standard of care and investigational therapies).\n5. Subjects must have at least 1 lesion that is measurable using RECIST Version 1.1 guidelines.\n\n   1. A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST Version 1.1, and has clearly progressed.\n   2. Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator (optional).\n6. Subjects must consent to provide archived tumor specimens for correlative biomarker studies. Tumor tissue must be identified and availability confirmed prior to initiation of study therapy. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.\n7. All subjects are encouraged to consent to and provide both pretreatment and on-treatment (optional) tumor biopsies.\n8. Eastern Cooperative Oncology Group (ECOG) Performance score of 2 or less.\n9. In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.\n10. Adequate organ function as determined by:\n\n    a) Hematological: i) Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL (1,000\u002Fmm3) ii) Absolute lymphocyte count (ALC) ≥ 0.5 × 109\u002FL (500\u002Fmm3) iii) Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3) without transfusion support within first 2 weeks prior to first dose iv) Hemoglobin ≥ 9.0 g\u002FdL without transfusion support within first 2 weeks prior to first dose b) Renal: i) Calculated creatinine clearance\\* (CrCl) or 24-hour urine CrCl \\> 50 mL\u002Fminute c) Hepatic: i) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); for subjects with documented\u002Fsuspected Gilbert's syndrome, bilirubin ≤ 3 × ULN ii) Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (AST and\u002For ALT can be up to 5 × ULN in the presence of liver metastasis, but cannot be associated with concurrent elevated bilirubin)\n11. Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product. The male partner of the female subject must use male condom plus, if locally available, spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Not engaging in sexual activity for the duration of the study is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\n    1. Females of childbearing potential are defined as those who are not surgically sterile (i.e., have not undergone bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n    2. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n    3. Subjects must refrain from breastfeeding while on study and for 180 days after the final dose of investigational product.\n\nExclusion Criteria:\n\n1. Subjects who have received prior therapy with regimens containing nivolumab or CTLA-4, PD-L1, PD-L2 or PD-1 antagonists or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.\n2. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n3. History of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the study drug formulations.\n4. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener's granulomatosis) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Graves disease, Hashimoto disease, autoimmune diseases that will be consider stable by hormones \u002Fsteroid replacement or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n5. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.\n6. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of the combination treatment; in the case of monoclonal antibodies, 28 days or 5 half-lives, whichever is shorter, prior to the first dose of the combination treatment.\n7. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.\n8. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE V5.0, Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss)\n9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of any treatment regimen. The following are exceptions to this criterion:\n\n   1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\n   2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent\n   3. Steroids as premedication for hypersensitivity reactions (e.g., computerized tomography (CT) scan premedication)\n10. History of primary immunodeficiency, solid organ transplantation, or tuberculosis.\n11. Test results indicating active infection with hepatitis B or C defined by positive Hepatitis B DNA, Hepatitis C RNA or known HIV infection.\n12. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of investigational products).\n13. Pregnant or breastfeeding women.\n14. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment regimen, or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable.\n15. Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast or non invasive bladder carcinoma that has\u002Fhave been surgically removed.\n16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, history of myocarditis, myocardial infarction ≤6 months, or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the subject to give written informed consent. In addition, participants with a left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiogram will be excluded.",{"count":300,"type":22},[25],"This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III\u002FIV ovarian cancer (OC).",[325,326,327],"Ovarian Cancer Stage IV","Ovarian Cancer Stage III","Ovarian Cancer Stage 3","2026-03-12",{"date":330,"type":33},"2026-03-16",{"date":63,"type":22},{"date":333,"type":22},"2028-11",{"name":39,"class":40},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},"100400808","phase-2-durvalumab-and-tremelimumab-in-combination-with-chemotherapy-in-hiv-infected-patients-with-non-small-cell-lung-cancer-100400808","NCT04499053","Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer","A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients with stage IV NSCLC who had undergone no previous systemic therapy for stage IV disease.\n2. Patients with HIV must be on an effective combination anti-retroviral therapy (cART) regimen for ≥ 4 weeks. Also, patients need to meet the following criteria.\n\n   * Documented HIV viral load \\\u003C 400 copies\u002FmL\n   * No AIDS-defining opportunistic infections within the last 12 months\n   * No concurrent incurable AIDS-defining malignancy\n3. Age \\> 18 years at time of study entry.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n5. Body weight \\>30kg\n6. Adequate normal organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,000 per mm3\n   * Platelet count ≥ 100,000 per mm3\n   * CD4 T-cell count ≥ 100 per mm3 for HIV-infected patients\n   * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n   * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n   * Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n   Males: Creatinine CL (mL\u002Fmin) = \\[Weight (kg) x (140 - Age)\\] \u002F \\[72 x serum creatinine (mg\u002FdL)\\] Females: Creatinine CL (mL\u002Fmin) = \\[Weight (kg) x (140 - Age) x 0.85\\] \u002F \\[72 x serum creatinine (mg\u002FdL)\\]\n7. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n   * Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n   * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n9. Must have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) and\u002For ALK translocations by locally approved laboratory testing including blood-based liquid biopsy.\n2. 2\\. Coinfection of HIV + HBV (coinfection of HIV and HBV allowed if the patient is on appropriate anti-viral therapy for HBV) or HIV + HCV (coinfection of HIV and HCV allowed if HCV is cured or patient is on appropriate anti-viral therapy for hepatitis C). Coinfection of HBV and HCV is allowed if otherwise eligible.\n3. No measurable disease.\n4. Receipt of the last dose of anticancer therapy (chemotherapy, targeted therapy) ≤ 21 days prior to the first dose of study treatment.\n5. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy (chemotherapy, targeted therapy, radiation therapy) with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n6. Patients who have had whole brain radiation therapy (WBRT) during the previous 2 weeks before treatment (no washout period is required for patients who have received stereotactic body radiation therapy).\n7. Subject has had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to starting study drug or has not recovered from side effects of such procedure (≥ grade 2 AE related to such procedure). Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and subject can be enrolled in the study ≥ 1 week after the procedure.\n8. History of allogenic organ transplantation.\n9. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n   i. Patients with vitiligo or alopecia ii. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement iii. Any chronic skin condition that does not require systemic therapy iv. Patients without active disease in the last 5 years may be included\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n11. Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n12. Previously untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients who have had whole brain radiation therapy (WBRT) during the previous 2 weeks before treatment (no washout period is required for patients who have received stereotactic body radiation therapy).\n13. Active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).\n14. Current or prior use of immunosuppressive medication within 7 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    i. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) ii. Systemic corticosteroids at doses not to exceed 20 mg\u002Fday of prednisone or its equivalent iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) iv. Decreasing dose of systemic corticosteroids after radiation therapy for brain metastasis.\n15. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of IP.\n16. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.\n17. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n18. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 within 12 months of the first dose of durvalumab.\n19. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":343,"type":22},18,[25],"This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection.",[347],"Carcinoma, Non-Small Cell Lung",[349,350,351,352],"Lung Cancer","Non-Small Cell Lung Cancer","Durvalumab","Tremelimumab",{"date":330,"type":33},{"date":355,"type":33},"2020-12-09",{"date":357,"type":22},"2027-12",{"name":39,"class":40},4,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":41},"100490059","phase-1-nerofe-and-doxorubicin-in-kras-mutated-st2-positive-solid-tumors-100490059","NCT05661201","NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors","Phase I Study of NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors","Inclusion Criteria:\n\n* Advanced\u002Funresectable or metastatic solid tumor with a pathogenic KRAS mutation via polymerase chain reaction (PCR), next-generation sequencing (NGS), or other standard test (blood-based DNA testing is allowed)\n* Presence of tumor ST2 expression via immunochemistry assay\n* Progression or intolerance to all standard therapies, patient may decline standard therapies and retain eligibility (patients must not have available curative options); patients must have been exposed to 2 or fewer lines of systemic therapy for advanced disease (these patients would decline any unused standard therapies which are still available)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Laboratory inclusion criteria:\n\n  * Absolute neutrophil count ≥ 1500\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL (transfusions are allowed to achieve this inclusion criterion)\n  * Platelets ≥ 100 x 109\u002FL (transfusions are NOT allowed to achieve this inclusion criterion)\n  * Creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m2 using the formula: creatinine clearance = \\[\\[140 - age(yr)\\]\\*weight(kg)\\]\u002F\\[72\\*serum Cr(mg\u002FdL)\\] (multiply by 0.85 for women).\n  * AST and ALT ≤ 3 x the upper limit of normal of the institution's normal range and total bilirubin ≤ 1.5 x the upper limit of normal of the institution's normal range - if liver metastases are present, AST and ALT ≤ 5 x the upper limit of normal of the institution's normal range and total bilirubin ≤ 3 x the upper limit of normal of the institution's normal range unless there is persistent nausea, vomiting, right upper quadrant pain, fever, rash, or eosinophilia\n  * Partial Thromboplastin Time (PTT) must be ≤ 1.5 × upper limit of normal of institution's normal range and INR (International Normalized Ratio) \\\u003C 1.5. Subjects on anticoagulation (such as warfarin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator\n* Patients must have fully recovered from all effects of surgery. Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring \"twilight\" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator\n* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and\u002For postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential\n* Patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures\n* Have measurable disease by RECIST v. 1.1\n* Have disease amenable to serial core tumor biopsies\n* Suitable, stable venous access to allow for all study-related blood sampling (a central line such as a portacath (e.g. Medi-Port) or PICC is highly encouraged)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Prior exposure to anthracycline chemotherapy\n* Receiving any active anti-cancer therapy while on study treatment\n* Brain metastases unless they have been previously treated with surgery and\u002For radiation at least 4 weeks prior to C1D1 and have a baseline MRI that shows no evidence of active\u002Fprogressing intracranial disease\n* Anti-tumor therapy within 3 weeks of C1D1 (defined as, but not limited to, cytotoxic chemotherapy, immunotherapy, biological therapy, radiotherapy, and investigational agents), the \"wash-out period\"\n* Concurrent severe illness or uncontrolled medical condition that, in the investigator's judgement, would cause unacceptable safety risks\n* Women who are pregnant or breastfeeding\n* Concurrent use of an aromatase inhibitor\n* Psychiatric illness or social situation that would limit compliance with study requirements\n* Concurrent malignancy or malignancy within 2 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer, or a malignancy that the investigator deems has been definitively treated (e.g. early stage prostate cancer)\n* Active hepatitis B, C, or HIV (patients with hepatitis C infection are eligible if they have an undetectable viral load following definitive treatment, patients with HIV are eligible if they have an undetectable viral load and a CD4 count above 500 cells\u002Fmm3)\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormalities, including any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening\n  * History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n  * Documented cardiomyopathy\n  * Left Ventricular Ejection Fraction (LVEF) \\\u003C50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening\n  * Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block)\n  * QTcF (using Fridericia's correction) of \\> 480 msec\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n    1. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia.\n    2. Concomitant use of medication(s) with a known risk to prolong the QT interval and\u002For known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication\n    3. Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)\n  * Systolic blood pressure (SBP) \\>160 mmHg or \\\u003C90 mmHg at screening",{"count":300,"type":22},[302],"The goal of this clinical trial is to learn about the safety of NEROFE and doxorubicin and how well it works in patients with advanced\u002Funresectable or metastatic solid KRAS-mutated and ST-positive solid tumors. The main question it aims to answer is to find the recommended dose and scheduled for the combination of NEROFE and doxorubicin. Participants will receive weekly doses of NEROFE and doxorubicin.",[371,372],"Solid Tumor","KRAS Mutation-Related Tumors","2026-03-04",{"date":375,"type":33},"2026-03-06",{"date":377,"type":33},"2023-04-12",{"date":379,"type":22},"2027-01",{"name":39,"class":40},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":191,"sex":75,"minAge":388,"maxAge":389,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":41},"100609989","pathtoscale-the-persist-trial-100609989","NCT07221747","PathToScale: The PERSIST Trial","ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL","Inclusion Criteria:\n\n•Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:\n\nIndividuals who are 15+ years old AND either\n\n1. Female sex workers (FSW) OR\n2. Men who have sex with men (MSM) OR\n3. Transgender individuals (TG) OR\n4. Women and adolescent girls and young women (AGYW) presenting at STI services and\u002For family planning and\u002For HIV testing services OR\n5. Breastfeeding women (BFW) OR\n6. Male partners of female sex workers and\u002For Men at high risk for HIV and\u002For men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.\n\nExclusion Criteria:\n\n* Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:\n\nThose living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.","15 Years","110 Years",{"count":391,"type":22},9900,[103],"The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high priority groups.",[395,396],"Oral Pre-exposure Prophylaxis (PrEP)","Long-acting Injectable Cabotegravir for PrEP","2026-03-02",{"date":373,"type":33},{"date":400,"type":33},"2026-02-16",{"date":402,"type":22},"2026-11",{"name":39,"class":40},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":75,"minAge":412,"maxAge":137,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":41},"100538441","phase-3-tobacco-education-and-lung-health-study-teal-100538441","NCT06290869","Tobacco Education and Lung Health Study (TEAL)","Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)","TEAL","Inclusion Criteria:\n\n* eligible for a screening or diagnostic scan,\n* USPSTF eligibility criteria (50-80 years old and \\>20-pack years);\n* currently smoking cigarettes (\\>1 in the past 30 days);\n* English speaking;\n* able to provide meaningful consent.\n\nExclusion Criteria:\n\n* prior lung cancer,\n* hearing impairment,\n* cognitive impairment,\n* household member already enrolled.","50 Years",{"count":414,"type":22},1188,[416],"PHASE3","Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.\n\nSecondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective.",[419],"Smoking Cessation",[421],"high risk for lung cancer","2026-02-13",{"date":424,"type":33},"2026-02-17",{"date":426,"type":33},"2024-02-22",{"date":428,"type":22},"2028-03-01",{"name":39,"class":40},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":449,"locationsCount":359},"100535183","phase-2-a-phase-ii-trial-of-sacituzumab-govitecan-in-patients-with-advanced-thymic-epithelial-tumors-100535183","NCT06248515","A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors","A Phase II Parallel Arm Study of SACITUZUMAB GOVITECAN-HZIY in Patients With Advanced Thymoma and Thymic Carcinoma","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years at time of signing informed consent form (ICF)\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with histologically confirmed advanced thymoma or thymic carcinoma\n* Patients who have experienced disease progression after treatment with at least one prior systemic therapy\n* Measurable disease per RECIST v1.1\n* Availability of pre-treatment tumor tissue (archival or fresh); If archival tissue is not available and a fresh biopsy is not considered safe and medically feasible by the Investigator, the patient may be approved for enrollment after consultation with the Principal Investigator\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:\n* Absolute neutrophil count (ANC) \\>\u002F= 1.5 x 10\\^9\u002FL (1500\u002FuL) without filgrastim support\n* Platelet count \\>\u002F= 100 x 10\\^9\u002FL (100,000\u002FuL) without transfusion\n* Hemoglobin (Hgb) \\>\u002F= 80 g\u002FL (8 g\u002FdL). Patients may be transfused to meet this criterion.\n* Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) \\\u003C\u002F= 2.5 x upper limit of normal (ULN), with the following exceptions:\n\n  * Patients with documented liver metastases: AST and ALT \\\u003C\u002F= 5 x ULN\n  * Patients with documented liver or bone metastases: ALP \\\u003C\u002F= 5 x ULN Serum bilirubin \\\u003C\u002F= 1.5 x ULN with the following exception: patients with known Gilbert disease: serum bilirubin \\\u003C\u002F= 3 x ULN\n* Creatinine clearance \\>\u002F= 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula, see Appendix 2)\n* For patients not receiving therapeutic anticoagulation: INR and aPTT \\\u003C\u002F= 1.5 x ULN\n* Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the final dose of study treatment. Women must refrain from donating eggs during this same period.\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\\>\u002F= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n  * Examples of contraceptive methods with a failure rate of \\> 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n  * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 90 days after the final dose of sacituzumab govitecan-hziy. Men must refrain from donating sperm during this this same period.\n  * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and 90 days after the final dose of sacituzumab govitecan-hziy to avoid potential exposure to the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\nExclusion Criteria:\n\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.\n* Symptomatic brain metastasis requiring corticosteroids. Patients with treated brain metastases are eligible.\n* No concurrent therapy with approved or investigational anticancer therapeutics",{"count":343,"type":22},[25],"The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy.\n\nThe main question it aims to answer is:\n\n• What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?\n\nParticipants will:\n\n* receive a fixed dose of 10 mg\u002Fkg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity\n* have regular blood tests, scans, and examinations to monitor their health.\n* have blood and a biopsy of their tumor for research purposes.",[441,442],"Thymoma","Thymic Carcinoma","2026-01-23",{"date":445,"type":33},"2026-01-27",{"date":447,"type":33},"2024-04-25",{"date":313,"type":22},{"name":39,"class":40},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":75,"minAge":456,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":41},"100540362","floss-project-facilitated-lessons-on-oral-and-systemic-health-in-survivors-100540362","NCT06315855","F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)","Inclusion Criteria:\n\n* male and female cancer survivors who are either ≥ 6 months after competing primary therapy for cancer treatment (N=100)\n* between 25-75 years of age\n* all race\u002Fethnic groups\n* own a smart phone.\n\nExclusion Criteria:\n\n* all head and neck\u002Foral cancer survivors\n* less then 25 years and older than 75 years of age\n* recurrence\u002Fsecond cancers or undergoing treatment\n* unable to provide informed consent.","25 Years","75 Years",{"count":101,"type":22},[103],"The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.",[462,463,464],"Oral Mucositis","Periodontal Diseases","Cancer","2026-01-20",{"date":467,"type":33},"2026-01-22",{"date":469,"type":33},"2024-08-20",{"date":471,"type":22},"2027-08-25",{"name":39,"class":40},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":41},"100581716","testing-a-web-based-intervention-for-radioactive-iodine-symptom-management-to-improve-health-related-quality-of-life-among-differentiated-thyroid-cancer-patients-100581716","NCT06853925","Testing a Web-based Intervention for Radioactive Iodine Symptom Management to Improve Health-related Quality of Life Among Differentiated Thyroid Cancer Patients","A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer","Inclusion Criteria:\n\n* Age 18 or older (papillary or follicular carcinoma)\n* Diagnosed with differentiated thyroid cancer\n* Received radioactive iodine (RAI) treatment less than or equal to three years ago.\n* Mild to moderate symptoms of RAI\n* Able to provide informed consent in English\n* Access to a computer, tablet, or smartphone with internet connectivity\n\nExclusion Criteria:\n\n* A condition that precludes providing informed consent or completing study procedures (cognitive or psychiatric condition, hearing problems) as identified by the patient's physician or as assessed by a trained study team member.",{"count":481,"type":22},88,[103],"The goal of this clinical trial is to learn if adult patients diagnosed with differentiated thyroid cancer can easily use and benefit from an online tool aimed to provide patients with educational resources and symptom management strategies to improve their quality of life after radioactive iodine (RAI) treatment. The main questions it aims to answer are:\n\n1. Can patients easily use and benefit from the RAI Support intervention?\n2. Does RAI Support improve health-related quality of life (overall well-being) compared to usual care?\n\nThis research will help test better digital tools to support thyroid cancer survivors in managing their health after RAI treatment.\n\nResearchers will compare RAI Support to treatment as usual (a publicly available informational website about thyroid cancer) to see if RAI Support works to improve patients' overall well-being.\n\nParticipants will:\n\n1. Receive access to RAI Support or an informational website (treatment as usual) for four weeks.\n2. Use the assigned website once a week for up to four weeks.\n3. Complete two online questionnaires (an initial questionnaire and a final questionnaire after four weeks of using the assigned website) about symptoms related to RAI treatment, mood, and confidence in managing symptoms.\n4. Complete an optional 60 minute virtual interview about your experiencing using the assigned website.",[485],"Thyroid Neoplasms",[487,488,489,490,491,492,493,494,495,496],"symptom burden","self efficacy","feasibility studies","internet-based intervention","pilot projects","neoplasms","radioactive iodine treatment","iodine radioisotopes","health-related quality of life","informational needs","2026-01-14",{"date":499,"type":33},"2026-01-16",{"date":501,"type":33},"2025-10-02",{"date":503,"type":22},"2027-02",{"name":39,"class":40},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":75,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":91},"100591413","use-of-a-decision-aid-to-resolve-uncertainty-about-radioactive-iodine-treatment-in-patients-with-intermediate-risk-thyroid-cancer-100591413","NCT06980103","Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer","Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer: The Radiance Trial","Inclusion Criteria:\n\n* Patients aged 18 and older\n* Patients diagnosed with intermediate risk DTC \\\u003C 6 months ago and who are making a decision about RAI treatment\n* Ability to understand the information conveyed in the informed consent form, pose questions and process answers (e.g., no cognitive impairment per direct consultation with the patient's physician), and, finally, provided informed consent to participate.\n* Participants willingness to be contacted and remain available to complete study activities throughout the duration of the study.\n\nExclusion Criteria:\n\n* Diagnosis of low risk or high risk DTC\n* Prior history of RAI\n* Clinical contraindications that prevent consideration of RAI (e.g., pregnancy, lactation, neutropenia if considering high dose of RAI)",{"count":513,"type":22},408,[103],"The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help participants make choices that reflect what matters most to them? - How does the decision aid compare to usual care in supporting patients through this decision? Participants who have been recently diagnosed with intermediate-risk differentiated thyroid cancer (DTC) will be randomly assigned to one of two groups. One group will receive a special decision aid website. This site includes detailed information about RAI, short videos, drop-down menus with extra details, exercises to help clarify values, and tools to help patients prepare questions for their doctor. The other group will receive the American Cancer Society (ACS) website. This site gives basic information about RAI but does not include interactive tools and is not specific to intermediate-risk thyroid cancer. Follow up surveys will be sent to the participants periodically, first at the start of the study, and again at 1 week, 4 weeks, and 6 months later.\n\nResearchers will compare how the two groups differ in making informed decisions. The decision aid is meant to support, not replace, a conversation with the medical team. Doctor recommendations remain an important part of treatment decisions.",[517],"Thyroid Cancer",[519,520,517,521,522,523],"Decision Aid","Radioactive Iodine Treatment","Intermediate Risk","Differentiated Thyroid Cancer","Intermediate risk DTC","2026-01-06",{"date":526,"type":33},"2026-01-08",{"date":528,"type":33},"2025-08-06",{"date":530,"type":22},"2029-07-31",{"name":39,"class":40},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":91},"100458986","phase-1-rage-inhibition-to-decrease-cardiotoxicity-in-women-with-early-breast-cancer-100458986","NCT05256745","RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer","RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer","RAGE","Inclusion Criteria:\n\n1. Patients must have clinical or pathologic stage I-III, histologically confirmed breast cancer, with any ER (estrogen-receptor), PR (progesterone receptors), or HER2 (human epidermal growth factor receptor 2) status who are planned to receive chemotherapy in the adjuvant or neoadjuvant setting.\n\n   a. Chemotherapy regimens administered per USPI (United States Prescribing Information) label: i. Dose dense doxorubicin plus cyclophosphamide followed by paclitaxel (ddAC\u002FddT) for 8 cycles ii. Docetaxel plus cyclophosphamide (TC) for 4-6 cycles iii. Docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)for 6 cycles iv. Chemotherapy regimen that includes ddAC, given at the end of the chemotherapy plan \\[can include: (1)weekly carboplatin + paclitaxel + pembrolizumab followed by pembrolizumab + dose dense doxorubicin and cyclophosphamide; (2) weekly carboplatin + paclitaxel followed by dose dense doxorubicin and cyclophosphamide; (3) weekly or dd paclitaxel followed by dose dense doxorubicin and cyclophosphamide\\]\n2. Patients must have had no prior chemotherapy\u002Fradiotherapy\u002For systemic therapy for early stage breast cancer, or any other malignancy\n3. Age ≥18 years.\n4. ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (Karnofsky ≥60%, see Appendix D).\n5. Patients must have normal organ and marrow function as defined below:\n\n   1. Leukocytes ≥3,000\u002FmcL (microliter)\n   2. Absolute neutrophil count ≥1,500\u002FmcL\n   3. Platelets ≥100,000\u002FmcL\n   4. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN)\n   5. AST(SGOT) (aspartate transaminase)\u002FALT(SGPT) (alanine aminotransferase) ≤1.5 × institutional ULN\n   6. Glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n6. Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated. If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.\n7. No pre-existing neurodegenerative disease or impairment, including history of CVA (cerebrovascular accident), or head injury.\n8. No psychiatric disorders which could interfere with their ability to consent. (Allowed psychiatric disorders may include but are not limited to: anxiety, depression, obsessive compulsive disorder, ADHD; as long as the disorder does not affect the ability to consent). Any other psychiatric disorders should be discussed with the Principal Investigator (PI) and will be allowed at the discretion of the PI.\n9. The effects of azeliragon on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients who have had prior chemotherapy, radiotherapy, systemic therapy, or hormonal therapy\n2. Patients with Stage IV breast cancer\n3. Patients who are receiving any other investigational agents.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to azeliragon, or the standard of care chemotherapy assigned, including: docetaxel, cyclophosphamide, carboplatin, doxorubicin, paclitaxel, trastuzumab, pertuzumab, pembrolizumab.\n5. Patients receiving any medications or substances that are strong CYP2C8 inhibitors are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Subjects who discontinue a strong CYP2C8 inhibitor must have discontinued the drug for at least 5 days or 5 half-lives of the drug, whichever is longer, before the first dose of study drug.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, neurogenerative disease\u002Fimpairment, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant women are excluded from this study as the risks of azeliragon to a fetus are unknown. There is unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azeliragon; breastfeeding should be discontinued if the mother is treated with azeliragon. These potential risks may also apply to other agents used in this study.\n8. History of cancer within the last 5 years except adequately treated cervical carcinoma-in-situ, or cutaneous basal cell or squamous cell cancer.",{"count":541,"type":22},48,[302,25],"This is a pilot study to evaluate the effects of azeliragon to decrease cardiac toxicity from chemotherapy and the safety of azelirgaon when given with chemotherapy. The Investigators hypothesize that there will be no significant interaction with Azeliragon and chemotherapy and that targeting the RAGE pathway will decrease anthracycline related cardiotoxicity and chemotherapy related cognitive decline.",[545,546],"Cancer Related Cognitive Decline","Non-metastatic Breast Cancer","2025-12-23",{"date":549,"type":33},"2025-12-24",{"date":551,"type":33},"2023-06-06",{"date":313,"type":22},{"name":39,"class":40},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":18,"minAge":561,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":568,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":41},"100602854","assessing-the-feasibility-of-web-based-insomnia-treatment-among-prostate-cancer-survivors-100602854","NCT07128927","Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors","SIESTA-P","Inclusion Criteria:\n\n* Age ≥21 years\n* Self-identifies as Black\u002FAfrican American\n* Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years\n* Has not received surgery, chemotherapy, or radiation within the previous 3 months\n* Has a smart phone, tablet, or computer with reliable internet access or willing to attend a weekly study appointment and to complete a weekly phone call\n* Has clinically relevant insomnia symptoms (i.e., score ≥10 on the Insomnia Severity Index)\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Employed in an occupation where sleep restriction could be a harm to themselves or others\n* Actively employed in shift work\n* Diagnosed with a severe\u002Fmajor psychiatric disorder\n* Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure\n* Unable to consent","21 Years",{"count":563,"type":22},40,[103],"This pilot study will recruit Black\u002FAfrican American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the treatment - cognitive behavioral therapy for insomnia - across 6 lessons, while the educational website is like an online patient brochure. The study will examine the feasibility of SHUTi to improve sleep and well-being among Black prostate cancer survivors. It will also examine whether SHUTi is acceptable to these survivors and will compare the effect of SHUTi versus the educational website on insomnia and non-insomnia patient-reported outcomes.",[567],"Insomnia",[569,570,571,572],"insomnia","Sleep Healthy Using the Internet (SHUTi)","prostate cancer survivorship","cognitive behavioral therapy for insomnia","2025-12-03",{"date":575,"type":33},"2025-12-05",{"date":577,"type":33},"2025-12-01",{"date":579,"type":22},"2026-09-01",{"name":39,"class":40},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":23,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":359},"100428963","phase-2-pembrolizumab-and-lenvatinib-in-advanced-cervical-cancer-100428963","NCT04865887","Pembrolizumab and Lenvatinib in Advanced Cervical Cancer","A Phase II Trial of Combination Therapy of Pembrolizumab and Lenvatinib in Patients With Locally Advanced or Metastatic Cervical Cancer","Inclusion Criteria:\n\n1. Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of locally advanced or metastatic cervical cancer will be enrolled in this study.\n2. Patients with progression or intolerance to at least one line of therapy in the locally advanced or metastatic setting will be eligible for this study.\n3. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n6. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 28 days prior to the date of treatment initiation.\n8. Have adequate organ function as defined. Specimens must be collected within 28 days prior to the start of study treatment.\n\n   1. Absolute neutrophil count (ANC) ≥1500\u002FµL\n   2. Platelets ≥100 000\u002FµL\n   3. Hemoglobin ≥9.0 g\u002FdL\n   4. Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n   5. Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n   6. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n   7. International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent.\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n4. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n5. Has received a live vaccine or live attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma) that have undergone potentially curative therapy are not excluded.\n9. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab or lenvatinib and\u002For any of their excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV).\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n19. Has uncontrolled blood pressure (BP) (Systolic BP\\>140 mmHg or diastolic BP\\>90 mmHg) in spite of an optimized regimen of antihypertensive medication.\n20. Has electrolyte abnormalities that have not been corrected.\n21. Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.\n22. Has bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n23. Subjects having \\> 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n24. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n25. Prolongation of QTc interval to \\>480 ms.",{"count":589,"type":22},35,[25],"This is a phase II trial of combination therapy of pembrolizumab and lenvatinib in patients with locally advanced or metastatic cervical cancer that had failed first line of therapy. The hypothesis is the combination of lenvatinib and pembrolizumab will overcome vascular endothelial growth factor (VEGF)-mediated immunosuppression to enhance the response of patients with locally advanced or metastatic cervical cancer.",[593,594],"Cervical Cancer","Metastatic Cervical Cancer","2025-10-03",{"date":597,"type":33},"2025-10-07",{"date":599,"type":33},"2022-10-07",{"date":601,"type":22},"2026-07",{"name":39,"class":40},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":192,"minAge":19,"maxAge":194,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":622,"locationsCount":41},"100584663","the-fyi-on-mri-a-multilevel-decision-support-intervention-for-screening-breast-mri-100584663","NCT06892275","The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI","Inclusion Criteria:\n\n* female\n* aged 18-74 years\n* self-identifying as Black and\u002For Latina\n* no personal history of breast cancer\n* English- or Spanish-speaking\n* having received a mammogram with normal results in the last 12 months\n* ≥20% lifetime breast cancer risk per the NCI Breast Cancer Risk Assessment Tool (BCRAT)\n\nExclusion Criteria:\n\n* aged \\\u003C18 or ≥75\n* pregnancy",{"count":225,"type":22},[103],"The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.",[613,614,615,616],"Breast Neoplasm Female","Early Detection of Cancer","Hereditary Breast and Ovarian Cancer Syndrome","Magnetic Resonance Imaging","2025-09-26",{"date":619,"type":33},"2025-09-30",{"date":240,"type":33},{"date":357,"type":22},{"name":39,"class":40},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":191,"sex":192,"minAge":19,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":161},"100449294","contigo---a-narrative-intervention-to-enhance-genetic-counseling-and-testing-100449294","NCT05130606","CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing","Testing a Narrative Intervention to Enhance Genetic Counseling and Testing","Inclusion Criteria:\n\nAim 1 and 2.\n\n* Self-identify as a Latina woman\n* Be 18 years old or older\n* Be able to provide informed consent\n* Be fluent in Spanish\n* Meet NCCN criteria to be considered for genetic cancer risk assessment for HBOC, whether by a personal history of cancer or family history of cancer\n* No previous participation in genetic counseling or testing for hereditary breast and ovarian cancer risk\n* No other family members are participating in this study\n* Have not participated in any previous studies involving interventions about HBOC or GCT\n\nAim 3.\n\n* Be 18 years old or older\n* Be fluent in English or Spanish\n* Have a role in the partner community clinic as either a) full-time or part-time employee b) intern c) volunteer\n\nExclusion Criteria:\n\n\\-",{"count":631,"type":22},332,[103],"This is a mixed-methods Hybrid Type 1 research design (efficacy study) in which we aim to conduct a two-arm randomized controlled trial and an Implementation Focused Process Evaluation of a culturally-targeted video and referral screening tool.\n\nIn this study, the investigators aim to evaluate the efficacy of a culturally targeted video previously developed by the research team vs. a Spanish-language fact sheet from an established group on enhancing genetic counseling and testing uptake and psychosocial outcomes in Latina women at risk for hereditary breast and ovarian cancer.\n\nThe investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using the Risk Screening Tool (RST) and video in community clinics.",[635],"Hereditary Breast and Ovarian Cancer",[637,638,639,640],"Breast cancer","Ovarian cancer","Hereditary cancer","Latinas","2025-08-22",{"date":643,"type":33},"2025-08-28",{"date":645,"type":33},"2021-06-01",{"date":647,"type":22},"2025-12-31",{"name":39,"class":40},""]