[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-cancer":35},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,63,111,135,189,201,234,259,286,316,338,366,392,413,435,457,488,515,541,576,601,650,684,706,741],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-100053405",false,"NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been 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 or oral corticosteroids within the previous 12 months\n* 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. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication 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. Subjects 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.\n  2. Subjects 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.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","18 Years","99 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[28,29,30,31,32,33,34,35,36],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[38,39,40,41,42,43,44,45,46,47,48,49],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":54},"2021-12-07",{"date":58,"type":21},"2027-06",{"name":60,"class":61},"University of Florida","OTHER",1,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":73,"type":21},100,"OBSERVATIONAL","This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[77,78,79,80,81,82,29,83,84,85,86,87,88,89,32,90,36,91,92,93,94,95,96,97,98,99,35],"Adenocarcinoma (NOS)","Anal Cancer","Bladder Cancer","Cervical Cancer","Endometrial Cancer","Esophageal Cancer","Gastrointestinal Stromal Tumour","Head and Neck Cancer","Liver Cancer","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Pancreatic Cancer","Renal Cell Carcinoma","Salivary Gland Cancer","Sarcoma","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","2026-06-26",{"date":102,"type":54},"2026-06-29",{"date":104,"type":54},"2025-09-18",{"date":106,"type":21},"2028-03-30",{"name":108,"class":109},"AstraZeneca","INDUSTRY",17,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":62},"100542204","ask-questions-in-gynecologic-oncology-asq-gyo-100542204","NCT06339827","ASk Questions in GYnecologic Oncology (ASQ-GYO)","ASk Questions in GYnecologic Oncology (ASQ-GYO): A Randomized Controlled Trial of a Question Prompt List Communication Intervention in Outpatient Gynecologic Oncology Clinics","ASQ-GYO","Inclusion Criteria:\n\n* 18 years of age\n* Understands spoken and written English\n* Able to consent to study participation\n* Biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical, vulvar, or vaginal cancer or Gestational Trophoblastic Disease) OR have imaging and\u002For laboratory findings highly concerning for a cancer diagnosis and have not seen a Gynecologic Oncologist\n\nExclusion Criteria:\n\n* pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial)\n* History and\u002For imaging\u002Flaboratory findings more indicative of a non-cancer diagnosis\n* Previous treatment discussion with a Gynecologic Oncologist",{"count":120,"type":21},70,[122],"NA","The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.",[32,81,80,35,99,125],"Gestational Trophoblastic Disease","2026-06-15",{"date":128,"type":54},"2026-06-17",{"date":130,"type":54},"2024-04-04",{"date":132,"type":21},"2028-05",{"name":134,"class":61},"Ira Winer",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":160,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100488427","phase-1-e7-t-cell-receptor-tcr--t-cell-induction-therapy-for-locoregionally-advanced-hpv-associated-cancers-100488427","NCT05639972","E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers","A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.\n2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative.\n10. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate aminotransferase (AST) (SGOT)\u002F alanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n11. Participants must be able to understand and be willing to sign the written informed consent document.\n12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.\n\nNote: Patients may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.\n2. Current treatment with another investigational agent.\n3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n5. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.\n6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.\n8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":143,"type":21},15,[24,25],"The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.\n\nThis study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.\n\nParticipants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.",[147,148,149,150,151,152,153,154,155,156,157,80,158,78,35,159,99],"HPV-Associated Cervical Carcinoma","HPV-Related Carcinoma","HPV-Related Malignancy","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV-Related Endocervical Adenocarcinoma","Oropharynx Cancer","Penile Cancer",[161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178],"HPV","Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","Chemoradiation","CAR-T, cell therapy","Tumor infiltrating lymphocyte","TCR","T cell","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy","2026-06-10",{"date":181,"type":54},"2026-06-12",{"date":183,"type":54},"2025-08-11",{"date":185,"type":21},"2026-10-01",{"name":187,"class":61},"Christian Hinrichs",2,{"id":190,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":26,"conditions":193,"keywords":194,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":200,"locationsCount":62},"100439284",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36],[38,39,40,41,42,43,44,45,46,47,48,49],"2026-06-04",{"date":197,"type":54},"2026-06-05",{"date":56,"type":54},{"date":58,"type":21},{"name":60,"class":61},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":208,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":62},"100496383","physical-activity-intervention-among-older-women-with-gynecologic-cancers-fit4treatment-100496383","NCT05743517","Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)","Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)","Inclusion Criteria:\n\n* Female; \\> 60 years of age\n* Diagnosis of endometrial\u002Futerine, ovarian, cervical or vulvar\u002Fvaginal cancer\n* Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.)\n* Willing to try to identify an exercise partner to participate with them, if needed\n* Fluent in English\n\nExclusion Criteria:\n\n* Uncontrolled cardiovascular disease or other major contraindications to physical activity\n* Active brain metastases\n* Cognitive or functional limitations that preclude a patient's ability to participate in the physical activity intervention\n* Pregnant women or prisoners","FEMALE","60 Years",{"count":211,"type":21},192,[122],"The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.",[215,81,216,80,217,35,99],"Ovary Cancer","Uterine Cancer","Cervix Cancer",[219,220,221,222,223,224],"behavioral intervention","physical activity","cancer outcomes","chemotherapy","systemic therapy","quality of life","2026-05-27",{"date":227,"type":54},"2026-05-29",{"date":229,"type":54},"2023-09-15",{"date":231,"type":21},"2029-08-01",{"name":233,"class":61},"Northwestern University",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":62},"100514523","phase-2-using-reiki-therapy-to-improve-symptoms-associated-with-brachytherapy-in-patients-with-gynecological-malignancies-100514523","NCT05979610","Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies","Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies","Reiki-Brachy","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.\n* Eligible to undergo brachytherapy treatment as an outpatient procedure.\n* Able to read and understand English and\u002For Spanish.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment.\n\nExclusion Criteria:\n\n* Prior brachytherapy treatment for a gynecological malignancy.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.",{"count":120,"type":21},[25],"The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies.\n\nParticipants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point.\n\nResearchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.",[246,247,248,81,80,99,35],"Gynecologic Neoplasm","Brachytherapy","Therapeutic Touch",[250],"Reiki","2026-05-06",{"date":253,"type":54},"2026-05-11",{"date":255,"type":54},"2023-11-14",{"date":58,"type":21},{"name":258,"class":61},"University of Utah",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100517924","phase-2-a-three-arm-randomized-phase-ii-study-of-dostarlimab-alone-or-with-bevacizumab-versus-nonplatinum-chemotherapy-in-recurrent-gynecological-clear-cell-carcinoma-dove-apgot-ov7-engot-ov80-study-100517924","NCT06023862","A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7\u002F ENGOT-ov80 Study)","A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07\u002F ENGOT-ov80 Study)","DOVE","Inclusion Criteria:\n\n1. Female patient is at least 18 years of age,\n2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.\n3. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva\n\n   * Local review by gynecologic pathologist required\n   * ≥50% clear cell histology in case of mixed carcinoma\n   * WT-1 neg (Only in case of ovarian cancer) Note: In the case of including non-ovarian clear cell carcinoma with more than 20 cases, the decision is made through discussion with the SPONSOR.\n4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Disease progression within 12 months of completing platinum-based chemotherapy\n6. 1-5 prior lines of therapies\n7. Patient with measurable disease according RECIST 1.1 criteria\n8. Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor block(preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted.\n9. Patients who consent to fresh tumor biopsies\n\n   * Confirmed with at least one lesion with location accessible to safely biopsy per the clinical judgement of the investigator\n   * Note: If mandatory biopsies cannot be performed as per investigator's clinical judgement, discussion and agreement between investigator and Sponsor are required.\n10. Patient has adequate organ function, defined as follows:\n\n    1. Absolute neutrophil count ≥ 1,500 cells\u002FμL\n    2. Platelets ≥ 100,000 cells\u002FμL\n    3. Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n    4. Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation for patients with creatinine levels \\> 1.5× institutional ULN\n    5. Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN\n    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN\n    7. International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN.Participants taking anticoagulants may be included on a stable dose with a therapeutic INR \\\u003C3.5. .\n11. Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of non-childbearing potential. If a negative result cannot be confirmed by a urine test, a serum pregnancy test is required. Non-childbearing potential is defined as follows:\n\n    1. Patient is ≥ 45 years of age and has not had menses for \\> 1 year.\n    2. A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for \\\u003C 2 years without a hysterectomy and oophorectomy.\n    3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation:\n\n       * Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan.\n       * Tubal ligation must be confirmed with medical records of the actual procedure.\n       * Information must be captured appropriately within the site's source documents.\n12. Patient of childbearing potential must agree to use a highly effective method of contraception with their partners starting from time of consent through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents).\n\nExclusion Criteria:\n\n1. Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.\n2. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n3. Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or \\\u003C 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.\n\n   Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed after discussion with the SPONSOR.\n4. Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor\n5. Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.\n6. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\n7. Patients with current abdominal\u002Fpelvic fistula\n8. Patient has a concomitant malignancy, or patient has a prior non-gynecological malignancy who has been disease-free for \\\u003C 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.\n9. Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging \\[using the identical imaging modality for each assessment, either MRI or CT scan\\] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.\n10. Patient has a known history of human immunodeficiency virus (HIV; HIV ½ antibodies). Participants with known human immunodeficiency virus(HIV) are allowed if they meet all of the following criteria:\n\n    * Cluster of differentiation 4(CD4) ≥350\u002FμL and viral load \\\u003C50 copies\u002FmL.\n    * No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months before enrollment.\n    * No history of HIV-associated malignancy for the past 5 years.\n    * Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \\>4 weeks before study enrollment.\n11. Patient with presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months before first dose of dostarlimab treatment.\n\n    * Participants who are hepatitis B surface antigen positive may be enrolled if their HBV-DNA level is below the institutional lower limit.\n    * Participants with chronic hepatitis B virus (HBV) infection who meet the criteria for anti-HBV therapy may be eligible if the participant is on a suppressive antiviral therapy before initiation of cancer therapy.\n    * Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA polymerase chain reaction is obtained. Hepatitis C participants may be eligible if they both have completed curative therapy and have a hepatitis C viral load \\\u003C!-- Not Allowed Tag Filtered --\\>\\\u003Cquantifiable limit.\n12. Patient has an active autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy is not considered a form of (eg, thyroid hormone or insulin).\n13. diagnosis immunodeficiency receiving steroid any other immunosuppressive within 7 days prior to first dose study treatment. Patients who have received acute and\\>\u002For low-dose systemic immunosuppressive medications (e.g,, a one-time dose of dexamethasone for nausea or chronic use of ≤ 10 mg\u002Fday of prednisone or dose equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the Sponsor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.\n14. Patient has not recovered (to Grade ≤ 1) from previous anti-cancer therapy-induced adverse events (AEs).\n\n    Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study.\n15. Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment\n16. Patient has a known hypersensitivity to bevacizumab or dostarlimab components or excipients.\n17. Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.\n18. Patient is considered a poor medical condition due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n19. Patients with known history of non-infectious pneumonitis that required steroids or has current pneumonitis.\n20. Use of any of the following immunomodulatory agents within 28 days prior to the first dose of study drug:\n\n    * Interferons\n    * Interleukins\n    * Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. mRNA and adenoviral-based COVID-19 vaccines are considered non-live and are not exclusionary. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n21. Patient who are pregnant or lactating, or plan to become pregnant or lactate during the expected duration of the study, from screening through 180 days after the last dose of study drug.",{"count":268,"type":21},198,[25],"Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +\u002F- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.\n\n198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio.\n\n1. Group A: Dostarlimab monotherapy\n\n   * First 3 cycles: Dostalimab 500mg every 3 weeks, IV\n   * 4 cycles \\~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV\n2. Group B: Dostarlimab + Bevacizumab combination therapy\n\n   * First 3 cycles: Dostalimab 500mg every 3 weeks, IV\n   * 4 cycles \\~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV\n   * Bevacizumab administered IV at 15 mg\u002Fkg every 3 weeks until disease progression or unacceptable toxicity\n3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)",[272,273,274,35,275,276],"Ovarian Neoplasms","Endometrial Neoplasms","Uterine Cervical Neoplasms","Vagina Neoplasm","Clear Cell Carcinoma","2026-04-30",{"date":251,"type":54},{"date":280,"type":54},"2024-01-22",{"date":282,"type":21},"2029-12-31",{"name":284,"class":61},"Yonsei University",27,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":188},"100554166","danish-vulva-cancer-recurrence-study-100554166","NCT06495554","Danish Vulva Cancer Recurrence Study","The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer","DaVulvaRec","Inclusion Criteria:\n\n* Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva\n* ≥ 18 years of age\n* Able to understand oral and written information in Danish\n\nExclusion Criteria:\n\n* Active treatment for concurrent cancer and\u002For dissemination of concurrent cancer",{"count":295,"type":21},1295,[122],"The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs.\n\nDaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. Furthermore, the investigators aim to examine if circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from VC patients. All patients will be followed for two years or until recurrence. Patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses.\n\nTotal number of patients to be included is 295 according to a power calculation. All patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from The Danish Gynecological Cancer Database. Hence, the control group will consist of 1000 VC patients diagnosed between 2011-2022.\n\nHypotheses:\n\n* All patients with VC will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctDNA at the time of diagnosis.\n* Measurement of ctDNA after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent VC.\n* Proactive use of repeated PROM assessments in combination with procedural actions during surveillance will allow early detection of recurrent VC and early identification of late effects after treatment.",[299,300,35,301,302,303,304,305,306],"Vulva Cancer","Vulva Neoplasm","Vulva Disease","Vulvar Neoplasms","Vulvar Diseases","PROM","Circulating Tumor DNA","Survivorship","2026-04-28",{"date":309,"type":54},"2026-04-29",{"date":311,"type":54},"2024-08-15",{"date":313,"type":21},"2030-12-31",{"name":315,"class":61},"University of Aarhus",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":324,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":62},"100519097","indocyanine-green-for-detection-of-sentinel-lymph-nodes-in-comparison-to-icg-plus-technetium-in-the-evaluation-of-vulvar-squamous-cell-carcinoma-100519097","NCT06039111","Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma","Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study","IGNITE-V","Inclusion Criteria:\n\nAdult women (18 years of age) with FIGO Stage IB (\\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and\u002For imaging and primary unifocal vulvar tumor size of \\\u003C 4 cm).\n\nExclusion Criteria:\n\nWomen with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.",true,{"count":326,"type":21},58,"The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.",[35],"2026-04-08",{"date":331,"type":54},"2026-04-13",{"date":333,"type":54},"2023-10-01",{"date":335,"type":21},"2026-11-30",{"name":337,"class":61},"Hamilton Health Sciences Corporation",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":324,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":348,"conditions":349,"keywords":353,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":62},"100550437","cancer-loyalty-card-study-2-clocs-2-100550437","NCT06447064","Cancer Loyalty Card Study 2 (CLOCS-2)","Cancer Loyalty Card Study 2: a Retrospective Observational Case-Control Study","(CLOCS-2)","Inclusion Criteria (ALL):\n\n* Individuals aged \\>18 years of age\n* Individuals must be residing in the United Kingdom at the time of giving informed consent\n* Individuals must be registered with an NHS GP Practice\n* Individuals must meet the criteria of ONE of the groups. For example, to be eligible for Group 1 (Cases), individuals must have been diagnosed with one of the following cancer types in the last 24 months: Bladder, colorectal (bowel), endometrial, liver, oesophageal, ovarian, pancreatic, stomach (gastric), uterine, or vulval; whereas for Group 2 (Controls), individuals must not have received a cancer diagnosis of any type in the last 6 years (except where the diagnosis was of non-melanoma skin cancer).\n* Individuals must be a primary registered cardholder\\* of one of the loyalty cards listed below, and consent to share their loyalty card data with the study team\n* Tesco Clubcard\n* Boots Advantage Card\n* Provision of written informed consent\n* Willing and able to comply with all required study activities\n\n  * The primary registered card holder, i.e., the person who is named on the loyalty card account, must also enrol into the study, if someone other than the registered primary card holder from the same household, wants to take part in the study.\n\nExclusion Criteria (ALL):\n\n* Individuals under the age of 18 years\n* Non-UK residents, at the time of giving informed consent\n* Individuals without an eligible loyalty card, or who have no one in their household who has an eligible loyalty card\n* Individuals who are not the primary registered cardholder in their household and where the primary registered loyalty card holder is not willing to join the study, and\u002For where the primary registered cardholder does not make purchases for or on behalf of the individual\n\nExclusion Criteria (CASES):\n\n• Individuals will not be able to join as a case if:\n\n* they have been diagnosed with an eligible cancer type more than 24 months ago (except where the diagnosis was non-melanoma skin cancer).\n* they have received an ineligible cancer diagnosis within the last 6 years except where the diagnosis was non-melanoma skin cancer).\n\nExclusion Criteria (Controls):\n\n• Individuals will not be able to join as a control (Group 2) if:\n\no they have received any cancer diagnosis in the last six years (except where the diagnosis was non-melanoma skin cancer).",{"count":347,"type":21},2900,"Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working.\n\nTherefore, early diagnosis is the most important way to improve cancer outcomes.Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person.\n\nThe major reasons for not presenting to the GP with symptoms such as these are \"not wanting to waste the GP's time\" and normalisation of these symptoms.\n\nThe persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician.\n\nRATIONALE FOR CURRENT STUDY\n\nAn early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor.\n\nInformation about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.",[90,350,351,352,85,79,216,35,32,81],"Colon Cancer","Oesophageal Cancer","Stomach Cancer",[32,354,355,356],"Epidemiology","Observational Study","Risk Assessment","2026-03-24",{"date":359,"type":54},"2026-03-25",{"date":361,"type":54},"2026-02-04",{"date":363,"type":21},"2027-04",{"name":365,"class":61},"Imperial College London",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":62},"100627041","phase-2-electrochemotherapy-for-recurrent-vulvar-cancer-100627041","NCT07443475","Electrochemotherapy for Recurrent Vulvar Cancer","Use of Electrochemotherapy in Women With Vulvar Cancer","Inclusion Criteria:\n\n* Local recurrence of vulvar cancer\n* Age ≥ 18 years\n* Expected life expectancy \\> 3 months\n* Karnofsky performance status ≥ 70 or WHO performance status ≤ 2\n* At least 2 weeks since last treatment\n* Ability to understand the procedure and possible adverse effects\n* Ability to provide written informed consent\n* Patient discussed at multidisciplinary tumor board before enrollment\n* Fit for anesthesia\n\nExclusion Criteria:\n\n* Life-threatening infection and\u002For severe cardiac, hepatic, or other systemic disease\n* Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)\n* Age \\\u003C 18 years\n* Major coagulation disorders not responding to standard therapy\n* Prior cumulative bleomycin dose ≥ 400 mg\u002Fm²\n* Chronic renal impairment (creatinine \\> 150 µmol\u002FL)\n* Epilepsy\n* Pregnancy\n* Inability to understand the study or refusal to participate",{"count":374,"type":21},13,[25],"This phase I\u002FII interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.",[35,378],"Recurrent Vulvar Cancer",[380,381,382],"Electrochemotherapy","Bleomycin","Vulvar carcinoma","2026-02-27",{"date":385,"type":54},"2026-03-02",{"date":387,"type":54},"2021-09-01",{"date":389,"type":21},"2026-08-31",{"name":391,"class":61},"Institute of Oncology Ljubljana",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":62},"100509557","immunotherapy-related-crp-kinetics-in-metastatic-gynecological-malignancies-100509557","NCT05914974","Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven metastatic gynecological malignancies irrespective of therapy line\n* patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group\n* planned ICI therapy in combination with palliative chemotherapy in the experimental group\n* patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group\n* written informed consent into ICK-Gyn\n\nExclusion Criteria:\n\n* missing indication for ICI therapy in the experimental group\n* any ICI therapy before inclusion into the trial\n* patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)",{"count":400,"type":21},120,"ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).",[403,80,81,32,35],"Gynecological Malignancies","2026-02-09",{"date":406,"type":54},"2026-02-10",{"date":408,"type":54},"2023-09-11",{"date":410,"type":21},"2035-04",{"name":412,"class":61},"University Hospital Tuebingen",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":62},"100483576","stratification-of-vulvar-squamous-cell-carcinoma-by-hpv-and-p53-status-to-guide-excision-100483576","NCT05576831","STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision","STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study","STRIVE","Inclusion Criteria:\n\n* Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma\n* Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease\n* Margin status after primary surgery:\n\n  * HPV-I VSCC: margins are negative for cancer but \\\u003C8mm, and\u002For positive for dVIN, and\u002For positive for p53 abnormality on IHC\n  * HPV-A VSCC: margins are negative for cancer but \\\u003C8mm (regardless of in-situ (HSIL) margin status)\n* Age ≥18 years old\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.\n\nExclusion Criteria:\n\n* Recurrent vulvar squamous cell carcinoma\n* Non-squamous cell carcinoma histotypes\n* FIGO stage III- IV disease\n* Patients referred for adjuvant radiation for close margins\n* Margins positive for cancer",{"count":422,"type":21},249,[122],"Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.",[35],"2026-01-31",{"date":428,"type":54},"2026-02-03",{"date":430,"type":54},"2024-11-25",{"date":432,"type":21},"2031-11-25",{"name":434,"class":61},"British Columbia Cancer Agency",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":62},"100285304","image-guided-gynecologic-brachytherapy-100285304","NCT02993900","Image-Guided Gynecologic Brachytherapy","A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the SKCCC at Johns Hopkins.\n* Site\u002FStage\n* Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:\n* Carcinoma of the cervix: Stage I-IVA or vaginal recurrence\n* Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence\n* Carcinoma of the vagina: Stage I-IVA or vaginal recurrence\n* Carcinoma of the vulva: Stage I-IVA or recurrence\n* Carcinoma of the urethra based on treating physician's discretion\n* Patients who have received prior radiation or chemotherapy may be enrolled on this study.\n* Age \\> 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.\n* Life expectancy of greater than 6 months.\n* ECOG performance status of \\\u003C2 or greater, based on treating physician's discretion\n* MRI of the pelvis or PET-CT within 4 months before registration\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Absolute neutrophil count \\\u003C 500 at the time of enrollment\n* A history of metal in the head or eyes","100 Years",{"count":444,"type":21},54,[122],"This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose of this study is to investigate the ability of MRI to successfully guide the placement of the brachytherapy applicator necessary to treat participants' gynecologic cancer. The Investigators want to see if the use of MRI will do a better job of assessing the tumor at the time of brachytherapy than the routinely used CT scan. The Investigators also want to determine if the use of MRI will enable doctors to reduce the radiation dose received by the body during the process of treating the tumor.",[80,216,99,35,79],"2025-12-16",{"date":450,"type":54},"2025-12-18",{"date":452,"type":54},"2016-12-15",{"date":454,"type":21},"2028-12",{"name":456,"class":61},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":471,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":188},"100568128","phase-2-belzutifan-in-recurrent-clear-cell-carcinoma-of-gynecologic-origin-100568128","NCT06677190","Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin","A Phase II Trial of Belzutifan in Patients With Recurrent or Persistent Clear Cell Carcinoma of the Ovary or Clear Cell Carcinoma of Other Gynecologic Origin","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of the ovary (CCOC) or clear cell carcinoma of other gynecologic origin (e.g., endometrial, cervical, vaginal, vulvar, endometriosis-related). If mixed histology, then ≥50% clear cell component.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.\n* Prior bevacizumab is allowed.\n* Prior use of immunotherapy is allowed.\n* Unlimited prior lines for the treatment of recurrent or persistent disease are allowed.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of Belzutifan in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 (Karnofsky performance scale ≥70%, see Appendix A).\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Hemoglobin ≥ 10.0 g\u002FdL (without use of erythropoietin; without packed red blood cell (RBC) transfusion within preceding 2 weeks)\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) (in the absence of liver metastases) or ≤ 5 x institutional ULN (in the presence of liver metastases)\n  * Creatinine ≤ 1.5 x institutional upper limit of normal (ULN) OR estimated creatinine clearance (CrCl) by the Cockcroft-Gault formula\n\n    ≥51mL\u002Fmin if creatinine \\> 1.5 x institutional ULN or institutional standard method\n  * INR OR PT and PTT ≤1.5 × institutional ULN unless participant is receiving anticoagulant therapy and PT\u002FINR or PTT are within therapeutic range of that anticoagulation\n* Participants with known brain metastases are eligible if they have completed primary CNS-directed therapy (such as surgical resection or radiotherapy) and if they have remained clinically stable, asymptomatic, radiologically stable without evidence of progression for at least 4 weeks by repeat imaging and have been off of steroids for at least 4 weeks prior to starting study treatment.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the Belzutifan, as determined after discussion with the Sponsor-Investigator, are eligible for this trial.\n* Archival tumor tissue must be available as 17 (15 unstained + 2 H\\&E) freshly serially cut slides from formalin-fixed, paraffin-embedded (FFPE) tissue blocks. The most recent available tissue is preferred to archived tissue. If fewer than 17 slides are available, the participant may still be eligible pending discussion with the Sponsor-Investigator.\n* The effects of Belzutifan on the developing human fetus are unknown. For this reason, women of child-bearing potential\\* must have a negative serum or urine pregnancy test at the Screening and Cycle 1 Day 1 visits. A negative serum or urine pregnancy test must be obtained within 24 hours before the first dose of study intervention in order to start receiving the study drug. Women of child-bearing potential and men must agree to use adequate contraception (see Appendix D) prior to study entry, for the duration of study participation, and for at least 30 days after last receipt of study therapy. Additionally, should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n\n  --Female participants who do not meet the definition of women of child-bearing potential must meet either criteria:\n  * Post-menopausal, defined as amenorrheic for at least 12 consecutive months within the appropriate age group and without an alternative medical cause OR\n  * Surgically sterilized (i.e. bilateral oophorectomy, bilateral tubal ligation or salpingectomy, or total hysterectomy)\n* Ability to swallow orally administered medications.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior use of Belzutifan or another HIF-2a inhibitor.\n* Participant has any of the following:\n\n  * Pulse oximeter reading \\\u003C92% at rest, or\n  * Requires intermittent supplemental oxygen, or\n  * Requires chronic supplemental oxygen\n* Anti-cancer treatment (chemotherapy, radiotherapy, or other investigational therapy) within 4 weeks prior to entering the study (6 weeks prior to study entry for nitrosoureas or mitomycin C).\n* Prior small molecule kinase inhibitor (including investigational kinase inhibitor) ≤ 2 weeks prior to entering the study.\n* Prior radiation therapy within 2 weeks of start of study drugs. Participants must have recovered from all radiation-related toxicities and must not require steroids. Participants must not have had radiation pneumonitis. Palliative radiation (≤2 weeks of radiotherapy) to non-CNS (central nervous system) disease is permitted, provided there is at least a 1-week washout prior to start of study drugs.\n* Use of herbal supplements, including but not limited to: cannabis, St. John's wort, gingko biloba, ginseng, saw palmetto, and ephedra. Herbal supplements must be stopped at least 1 week prior to beginning study treatment.\n* Participants who are known to require concomitant therapy with moderate or strong CYP3A4 inducers. Due to potential drug interactions, concomitant use of these medications is not permitted for the duration of treatment on trial. Participants are eligible for study entry if an appropriate substitution is made prior the first dose of study medication.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n* Participants who have AEs due to previous anticancer therapies must have recovered to\n\n  * Grade 1 or baseline with the exception of alopecia. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have\n  * Grade 2 neuropathy are eligible.\n* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines are allowed.\n\nNote: Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, replication-incompetent adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.\n\n* Major surgical procedures within 4 weeks of beginning study treatment are not allowed. Minor surgical procedures (with the exception of port placement) within 1 week of beginning study treatment are not allowed.\n* Any gastrointestinal disorder that would interfere with the passage or absorption of oral medications. Participants must be able to swallow oral medications. Participants with an enteric tube (e.g., gastrostomy or jejunostomy tube), receiving total parenteral nutrition (TPN), or dependent on IV fluid support are ineligible.\n* Participants with significant cardiovascular impairment, including uncontrolled hypertension, congestive heart failure of New York Heart Association Grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia within the past 6 months.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has received colony-stimulating factors (e.g., G-CSF, GM-CSF, or recombinant EPO)\n\n  ≤28 days prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency.\n* Is known to be positive for Human Immunodeficiency Virus (HIV). Subjects with HIV, including those on antiretroviral therapy, are excluded due to risk of immunodeficiency and risk of overlapping toxicity.\n* Is known to be positive for Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Participants are eligible if they have a history of HCV infection that has been treated and cured, with an undetectable viral load.\n* Participants with uncontrolled intercurrent illness, including but not limited to active infection and serious non-healing wounds or ulcers.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Participants with a history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological composition to belzutifan.\n* Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with belzutifan, breastfeeding participants are excluded from this study.\n* History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":465,"type":21},32,[25],"The purpose of this research study is to see if the study drug Belzutifan is effective and safe for participants with clear cell gynecologic malignancy, including but not limited to, ovarian cancer, endometrial cancer, cervical cancer, vaginal cancer, vulvar cancer, or endometriosis-related cancer.\n\nThe name of the study drug involved in this study is:\n\n\\- Belzutifan (a type of Hypoxia-Inducible Factor-2 alpha (HIF-2a) inhibitor)",[32,469,81,216,80,35,470,99],"Ovarian Carcinoma","Gynecologic Cancer",[32,469,472,473,474,475,476,477,216,81,80,35,478,470,99],"Persistent Clear Cell Ovarian Carcinoma","Recurrent Clear Cell Ovarian Carcinoma","Clear Cell Uterine Carcinoma","Clear Cell Endometrial Carcinoma","Clear Cell Cervical Carcinoma","Clear Cell Vulvar Carcinoma","Gynecologic Malignancy","2025-11-03",{"date":481,"type":54},"2025-11-05",{"date":483,"type":54},"2024-12-20",{"date":485,"type":21},"2029-06-30",{"name":487,"class":61},"Dana-Farber Cancer Institute",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":506,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":188},"100376977","serial-mri-scans-during-radiation-therapy-100376977","NCT04188535","Serial MRI Scans During Radiation Therapy","RELAY: Repeated Magnetic Resonance Imaging Examinations to Analyze and Assess Your Cancer: A Prospective Study on the Use of Serial Magnetic Resonance Imaging in the Assessment of Changes During Treatment With Radiation Therapy","RELAY","Inclusion Criteria:\n\n* Participants must have a confirmed malignancy requiring radiation therapy.\n* Age: 18 years or older except where otherwise specified in subprotocol.\n* ECOG performance status ≤2 (Karnofsky ≥60%)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Any further criteria listed in the specific disease site subprotocol.\n* (Esophageal cohort) Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy. Patients must have an endoscopic ultrasound done or scheduled to be done at the baseline visit.\n* (Glioblastoma cohort) Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care.\n* (Prostate cohort) Patients with localized prostate cancer who are planning to receive androgen deprivation therapy and definitive radiation therapy.\n* (Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned.\n* (Pediatric glioma cohort) Patients age 18 or under (patients 18-30 years old are also eligible if the physician determines that based on genetics, the tumor biology is consistent with pediatric high grade glioma). Patients with a histologically confirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will be undergoing radiation therapy as part of clinical care. Patients with DIPG are only eligible if biopsy-confirmed high grade DIPG is present. Ability to understand and\u002For willingness of their parent or legally authorized representative to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Disease-specific exclusion criteria will be specified in a subprotocol.\n* For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast. If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility.\n* Inability to undergo magnetic resonance imaging (MRI).",{"count":497,"type":21},149,[122],"This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.\n\nThe research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.\n\nThe research study procedures include:\n\n* Screening for eligibility\n* Three MRI scans",[501,82,502,503,504,36,35,505],"Glioblastoma","Radiotherapy","Magnetic Resonance Imaging","MRI","Pediatric Glioblastoma Multiforme",[501,82,502,503,504,36,35,505],"2025-08-20",{"date":509,"type":54},"2025-08-26",{"date":511,"type":54},"2020-01-15",{"date":513,"type":21},"2030-07-31",{"name":487,"class":61},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":324,"sex":208,"minAge":522,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":62},"100290490","screening-for-anal-cancer-in-women-with-high-grade-vulvar-dysplasia-or-vulvar-cancer-100290490","NCT03061435","Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.","Vulvar-AIN","Inclusion Criteria:\n\n* Women age ≥ 40\n* Previous diagnosis of VIN 2\u002F3 or vulvar\n\nExclusion Criteria:\n\n* Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer\n* Women who are HIV positive\n* Women currently taking immunosuppressant medication\n* Women who have had a previous hysterectomy","40 Years",{"count":524,"type":21},110,[122],"Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.\n\nHypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2\u002F3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2\u002F3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.",[35,80,528,529,78,530,154],"Vulvar Dysplasia","Cervical Dysplasia","Anal Dysplasia",[35,80,528,529,78,530,161],"2025-05-13",{"date":534,"type":54},"2025-05-16",{"date":536,"type":54},"2021-02-01",{"date":538,"type":21},"2026-01-01",{"name":540,"class":61},"Dr. Danielle Vicus",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":553,"conditions":554,"keywords":559,"overallStatus":566,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":62},"100583089","phase-4-near-infrared-fluorescence-imaging-with-indocyanine-green-to-evaluate-bowel-anastomoses-in-gynecologic-oncology-surgery-100583089","NCT06871787","Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery","Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green","INOCA","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n* Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment.\n* Planned bowel resection and anastomosis during gynecologic oncology surgery.\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to indocyanine green (ICG).\n* Pregnancy or breastfeeding at the time of surgery.\n* Severe liver or kidney dysfunction limiting the use of ICG.",{"count":550,"type":21},50,[552],"PHASE4","The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations.\n\nThe main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment.\n\nResearchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.",[555,32,556,557,35,558],"Gynecologic Cancers","Endometrial Cancers","Cervical Cancers","Anastomotic Leaks",[560,561,562,563,564,565],"Indocyanine Green","Near-Infrared Imaging","Bowel Anastomosis","Gynecologic Oncology","Anastomotic Complications","Perfusion Assessment","NOT_YET_RECRUITING","2025-03-11",{"date":569,"type":54},"2025-03-14",{"date":571,"type":21},"2025-09-01",{"date":573,"type":21},"2027-12-30",{"name":575,"class":61},"Istanbul University",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":589,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":600},"100510882","phase-2-ak104-for-recurrent-or-metastatic-vulvar-cancer-100510882","NCT05932212","AK104 for Recurrent or Metastatic Vulvar Cancer","A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer","Inclusion Criteria:\n\nAge \\>=18 and \\\u003C=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy.\n\nFor Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy.\n\nAt least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception\n\nExclusion Criteria:\n\nSubjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc.\n\nSystemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration.\n\nPrevious treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.).\n\nActive or potentially recurrent autoimmune disease.","80 Years",{"count":585,"type":21},20,[25],"This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.",[35],[590,47],"PD-1\u002FCTLA-4","2025-03-10",{"date":593,"type":54},"2025-03-12",{"date":595,"type":54},"2023-08-25",{"date":597,"type":21},"2025-12-15",{"name":599,"class":109},"Akeso",6,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":16,"minAge":607,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":610,"conditions":611,"keywords":636,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":62},"100531692","nyscf-scientific-discovery-biobank-100531692","NCT06203106","NYSCF Scientific Discovery Biobank","Inclusion Criteria:\n\n* Age 30 days or older.\n* Diagnosis and\u002For medical history of a condition, disease, genetic background, or trait of interest or healthy control.\n* Adults with decisional capacity must provide written informed consent unless physical limitations preclude signing.\n* Adults without decisional capacity to consent must a have diagnosis of Amyotrophic Lateral Sclerosis (ALS), Alzheimer's Disease and Related Dementias (AD\u002FADRD); Batten Disease, Corticobasal Degeneration (CBD), Dementia, Frontotemporal Dementia (FTD), Huntington Disease, Lewy Body Disease, Multiple Sclerosis, Multiple System Atrophy, Parkinson's Disease (PD), Parkinsonism, and\u002For Progressive Supranuclear Palsy, and must provide assent; a legally authorized representative (LAR) must also provide written informed consent.\n* Minors undergoing skin collection for research purposes must have a condition, disease, genetic background, or trait of interest and parental\u002Fguardian consent.\n* Minors undergoing blood, and\u002For saliva collection for research purposes may have a condition, disease, genetic background, or trait of interest or serve as a healthy control and must have an available parent\u002Fguardian to provide consent.\n* Minors transferring biological samples and associated data from a procedure outside of the research may have a condition, disease, genetic background, or trait of interest or serve as a healthy control and must have an available parent\u002Fguardian to provide consent.\n\nExclusion Criteria:\n\n* Wards of the state.\n* For prospective skin samples: history of keloid formation, coagulation disorder, or allergy to the anesthetic.\n* For prospective blood samples: history of coagulation disorder.\n* For all prospective sample collections: 1) Subjects who refuse to adhere to NYSCF's and\u002For a collection site's safety protocol(s) will be excluded; 2) Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter (mcL) of blood will be excluded due to increased risk of infection.","30 Days",{"count":609,"type":21},10000,"The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use.\n\nThrough this research, researchers hope to identify future treatments or even cures for the major diseases of our time.",[612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,32,80,216,99,35,634,635],"ALS","Amyotrophic Lateral Sclerosis","Alzheimer Disease","Alzheimer Disease, Early Onset","Alzheimer Disease, Late Onset","Batten Disease","Corticobasal Degeneration","Dementia","Frontotemporal Dementia","Huntington Disease","Lewy Body Disease","Multiple Sclerosis","Multiple System Atrophy","Parkinson Disease","Parkinson's Disease and Parkinsonism","Progressive Supranuclear Palsy","INAD","Diabetes","Diabetes Mellitus","Diabetes Mellitus, Type 2","Diabetes Mellitus, Type 1","Macular Degeneration","PTSD","Post Traumatic Stress Disorder",[612,613,614,617,618,619,620,621,622,623,624,625,637,627,628,629,638,639,633,640,32,80,216,99,35,634,635],"Parkinsonism","Diabetes Type 1","Diabetes Type 2","Women's Reproductive Cancer","2025-02-27",{"date":643,"type":54},"2025-03-03",{"date":645,"type":54},"2022-11-10",{"date":647,"type":21},"2045-11-10",{"name":649,"class":61},"New York Stem Cell Foundation Research Institute",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":324,"sex":208,"minAge":17,"maxAge":583,"enrollmentInfo":657,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":659,"conditions":660,"keywords":664,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":62},"100057410","specimen-and-data-study-for-ovarian-cancer-early-detection-and-prevention-100057410","NCT00005095","Specimen and Data Study for Ovarian Cancer Early Detection and Prevention","Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study","DISEASE CHARACTERISTICS:\n\n* Meets one of the following criteria:\n\n  * Considered to be at increased risk for developing ovarian cancer, as defined by one of the following:\n\n    * Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer\n    * Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and\u002For pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1\u002F2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor\n    * A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer\n    * Increased risk as deemed by a certified genetic counselor\n  * Undergoing surgery for a gynecologic condition, including any of the following:\n\n    * Diagnosis of a reproductive cancer\n    * Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)\n    * Highly suspicious adnexal mass\n    * Risk-reducing prophylactic oophorectomy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Between the ages of 18 and 80",{"count":658,"type":21},6000,"RATIONALE: To improve strategies for detection and prevention of early-stage disease.\n\nPURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.",[80,81,661,662,32,93,663,99,35],"Fallopian Tube Cancer","Hereditary Breast\u002FOvarian Cancer (brca1, brca2)","Uterine Leiomyomata",[665,666,667,668,669,670,671,672,673,674,47,675],"ovarian epithelial cancer","hereditary breast\u002Fovarian cancer (BRCA1, BRCA2)","fallopian tube cancer","ovarian germ cell tumor","ovarian sarcoma","ovarian stromal cancer","endometrial cancer","uterine sarcoma","vaginal cancer","cervical cancer","uterine leiomyomata","2025-02-26",{"date":678,"type":54},"2025-02-28",{"date":680,"type":54},"2000-03",{"date":682,"type":21},"2040-12",{"name":233,"class":61},{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":693,"conditions":694,"keywords":4,"overallStatus":566,"whyStopped":4,"lastUpdateSubmitDate":697,"lastUpdatePostDateStruct":698,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":62},"100560819","understanding-the-rarest-gynecological-cancers-a-multi--omics-platform-for-improved-patients-management-100560819","NCT06582108","UNDERSTANDING the RAREST GYNECOLOGICAL CANCERS: a MULTI -OMICS PLATFORM for IMPROVED PATIENTS MANAGEMENT","ROAR","Inclusion Criteria:\n\n* \\>18 years old\n\nHistological diagnosis of:\n\nNon-epithelial ovarian tumors Uterine sarcomas Vulvar cancer\n\nExclusion Criteria:\n\n* Active HIV, HBV, or HCV infection Synchronous neoplasms Non-rare histologies of gynecological malignancies",{"count":692,"type":21},190,"Rare gynecological cancers including uterine sarcomas, vulvar and non-epithelial ovarian cancers, are under-studied diseases and the absence of standardized diagnostic and therapeutic approaches or tailored clinical guidelines led to low survival rates and\u002For poor quality of life outcomes.\n\nThe ROAR project aims at increasing the molecular understanding of these diseases in a multidisciplinary, interinstitutional setting including gynecologic oncologists, medical oncologists, phase I researchers, pathologists, molecular pathologist, research nurses, genetists, bioinformatics, psychologists and patients' advocacy groups.\n\nThe project will pursue this aim through the following activities:\n\n1. Harmonizing procedures and enabling safe and easy data sharing across all involved institutions; this will be achieved by reviewing the available clinical and molecular data (WP1), establishing an interinstitutional second-opinion board (WP2\u002FTask1), developing a dedicated electronic customized research form (WP2\u002FTask2) and deploying a genomics platform (WP2\u002FTask3).\n2. Performing comprehensive somatic and transcriptional profiling as well as immunological landscape assessments on high quality annotated samples stored in a biobank dedicated to rare gynecological cancers; this will require systematic and standardized clinical data and biological samples collection (WP3\u002FWP4), standardization of pre-analytical and sequencing procedures (WP5\u002F6). The board will tailor indications and modalities for genomics and liquid biopsy assessments based on clinical features.\n3. Evaluating the clinical impact of the board on rare gynecological cancers management and, through the evidence gathered, implementing diagnostic and therapeutic strategies; this will include analyzing the activities of the board (WP7\u002FTask 1.1), integrating -omics data in the board report (WP7\u002FTask 1.2), evaluating liquid biopsy role in identifying minimal residual disease post-surgery, disease monitoring over time, capability of capturing tumor heterogeneity at baseline and identifying hot spot actionable molecular alterations. Finally, the evidence gathered from the ROAR project, will allow update of clinical guidelines or provide new recommendations for each rare gynecological cancer included. The results of ROAR will also be disseminated through direct access to the integrated platform developed.",[695,35,696],"Uterine Sarcoma","Non Epithelial Ovarian Cancers (NEOC)","2024-08-30",{"date":699,"type":54},"2024-09-03",{"date":701,"type":21},"2024-09-15",{"date":703,"type":21},"2026-12-31",{"name":705,"class":61},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":707,"slug":708,"hasResults":12,"nctId":709,"briefTitle":710,"officialTitle":711,"acronym":4,"eligibilityCriteria":712,"healthyVolunteers":324,"sex":208,"minAge":713,"maxAge":714,"enrollmentInfo":715,"targetDuration":4,"studyType":22,"phases":717,"briefSummary":719,"conditions":720,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":732,"lastUpdatePostDateStruct":733,"startDateStruct":735,"completionDateStruct":737,"leadSponsor":739,"locationsCount":62},"100394922","phase-3-evaluate-the-efficacy-immunogenicity-and-safety-of-9-valent-hpv-recombinant-vaccine-in-chinese-healthy-females-100394922","NCT04422366","Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females","A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years","Inclusion Criteria:\n\n(If the \"\\*\" option is not met during screening, the visit can be rescheduled)\n\n* Chinese women aged 20-45 who can provide legal identification and have a sexual life history;\n* The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent;\n* Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements;\n* Subjects have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal;\n* \\*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to refrain from sexual intercourse (including anal, vaginal, or genital\u002Fgenital contact of the same or opposite sex) for 48 hours prior to any visit that includes gynecological sample collection, and to refrain from vaginal flushing, vaginal cleansing, or use of vaginal medications or preparations for 72 hours;\n* When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU\u002Fml cox-hcg), they were not in the lactation period and had no family planning within 7 months after enrollment (1 month before whole-course inoculation).2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures include: the pill, injection or embedded contraception, slow-release local birth control pills, hormone patch, the intrauterine device (IUD), sterilization, abstinence, condom (men), diaphragm, cervical cap, etc.), rhythm, withdrawal and emergency contraception is unacceptable contraception;\n* \\*body temperature \\\u003C37.3℃ (underarm body temperature)\n\nExclusion Criteria:\n\nFirst dose exclusion criteria(If the \"\\*\" option is met during screening, the visit can be rescheduled)\n\n* Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine and have received a vaccine\u002Fplacebo vaccination;\n* Previous positive history of HPV;\n* Has a history of abnormal cervical cytology, including squamous intraepithelial lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H), atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;\n* Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.);\n* Received total hysterectomy or pelvic radiotherapy;\n* Cervical insufficiency or abnormal cervical structure (judged by the results of routine gynecological examination);\n* Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal) or have obvious condyloma;\n* A history of seizures, convulsions or convulsions, or a family history of mental illness;\n* Have participated in other gynecology-related clinical trials within 6 months, and have used or plan to use other investigational or unregistered products (drugs or vaccines) other than the vaccine in this study within 3 months;\n* A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.A history of severe adverse reactions to previous vaccinations or a history of severe allergies to any of the components of the vaccine under study (histidine, polysorbate, aluminum phosphate, sodium borate, amorphous aluminum phosphate sulfate adjuvant and water for injection) (such as swelling of the mouth and throat, dyspnea, hypotension or shock, severe urticaria, etc.);\n* Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination, or plans to receive such product within the next 7 months (1 month prior to the full course of vaccination);\n* Subjects present\u002Fpresent with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;\n* Immunosuppressant therapy within 1 month before the first dose of vaccination, such as long-term use of systemic glucocorticoid therapy (≥2mg\u002Fkg\u002F day, for more than 2 weeks, such as prednisone or similar drugs;Topical administration (such as ointment, eye drops, inhalant or nasal spray) not exceeding the recommended dosage in the directions or showing any signs of systemic exposure) or planning to receive such treatment within the next 7 months (1 month before the full course of inoculation);\n* Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;\n* Patients with severe liver, kidney and cardiovascular diseases, diabetes or malignant tumor with complications;\n* Patients with thrombocytopenia or any coagulation disorders that may be contraindications to intramuscular injection;\n* \\* subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;\n* \\* an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);\n* \\* the first dose of vaccine was in pregnancy at the time of vaccination, or the end of pregnancy had not exceeded 6 weeks;\n* \\* after questioning, subjects had fever symptoms (subaxillary body temperature ≥37.3℃) before the first day of vaccination (within 24 hours before vaccination);\n* \\* the subject is in the menstrual period;\n* \\* severe acute vaginitis and suppurative cervicitis found by naked eye during gynecological examination (purulent secretion visible by naked eye);\n* Blood pressure on physical examination before the first dose of vaccination was higher than normal or increased (systolic blood pressure ≥140mmHg and\u002For diastolic blood pressure ≥90mmHg);\n* Gynecological examination before the first dose of vaccination suspected genital warts, or on the basis of clinical symptoms and signs suspected vulva, vagina or cervical precancerous lesions and the possibility of cancer;\n* Subjects may be unable to comply with the study procedure, comply with the agreement, or plan to permanently relocate from the region prior to completion of the study, or may be permanently absent from the region during the scheduled visit;\n* In the opinion of the investigators, the subjects had any other factors that made them unsuitable to participate in the clinical trial, so that continued participation in the study could not guarantee the maximum benefit of the subjects.\n\nSecond and third doses of vaccine were excluded criteria\n\n* new discoveries or new occurrences that meet the first dose exclusion criteria (except for articles 2, 3, 4, 21);\n* other serious adverse events: the investigator decides whether to terminate the experimental vaccination according to its treatment needs;\n* the investigator assays for any other reasons that may be considered necessary to terminate the trial vaccination.\n\nSecond and third doses of vaccine were delayed criteria\n\nVaccination may be postponed if:\n\n* fever (underarm body temperature ≥37.3℃);\n* before inoculation (on the day of inoculation), the urine pregnancy test was positive (sensitivity was 25mIU\u002Fml n-hcg);\n* acute illness or acute attack of a chronic disease or use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days before vaccination;\n* insufficient interval between other vaccines (inactivated or recombinant vaccines received within 14 days prior to vaccination, or any live attenuated vaccine received within 28 days);\n* any immunoglobulin or blood products received during vaccination should be administered at least 3 months after the vaccination;\n* other circumstances that can be postponed as judged by the researcher.","20 Years","45 Years",{"count":716,"type":21},8000,[718],"PHASE3","This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .",[80,35,99,721,722,723,724,725,726,727,728,729,730,731],"CIN1","CIN2","CIN3","VaIN1","VaIN2","VaIN3","Genital Wart","VIN 1","VIN 2","VIN 3","AIS","2024-06-06",{"date":734,"type":54},"2024-06-07",{"date":736,"type":54},"2020-04-28",{"date":738,"type":21},"2029-09-15",{"name":740,"class":109},"Shanghai Bovax Biotechnology Co., Ltd.",{"id":742,"slug":743,"hasResults":12,"nctId":744,"briefTitle":745,"officialTitle":746,"acronym":747,"eligibilityCriteria":748,"healthyVolunteers":12,"sex":208,"minAge":17,"maxAge":4,"enrollmentInfo":749,"targetDuration":751,"studyType":74,"phases":4,"briefSummary":752,"conditions":753,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":755,"lastUpdatePostDateStruct":756,"startDateStruct":758,"completionDateStruct":760,"leadSponsor":762,"locationsCount":62},"100518358","optical-guided-sentinel-node-biopsy-for-staging-of-vulvar-cancer-i-100518358","NCT06029504","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer","SENTIVUC","Inclusion Criteria:\n\n* Patients with primary vulva cancer, FIGO stage IB (tumor \\\u003C 4 cm)\n* Patients with unifocal recurrence in the vulva (tumor \\\u003C 4 cm) located on the side where the patient is surgically naïve in the groin\n\nExclusion Criteria:\n\n* Prior irradiation of the vulva or groins\n* Prior SNB or inguinal lymphadenectomy in the relevant groin\n* Known allergy to ICG or iodine (ICG contains 5% sodium iodine)",{"count":750,"type":21},115,"1 Year","The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \\\u003C 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \\\u003C 4 cm.",[35,754],"Sentinel Lymph Node","2023-11-29",{"date":757,"type":54},"2023-12-06",{"date":759,"type":54},"2023-01-01",{"date":761,"type":21},"2027-12-31",{"name":763,"class":61},"Rigshospitalet, Denmark"]