[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,59,100,128,190,216,278,311,343,368,392,423,448,470,497,520,617,641,668,692,718,743,767,788,808],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545",false,"NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma","RECRUITING","2026-07-01",{"date":49,"type":50},"2026-07-02","ACTUAL",{"date":52,"type":50},"2026-02-11",{"date":54,"type":21},"2027-08-31",{"name":56,"class":57},"Alliance for Clinical Trials in Oncology","OTHER",18,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"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":69,"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",[73,28,74,31,33,34,35,75,40,38,76,77,78,79,41,42,43,80,81,45,82,83,84,85,86,87,88],"Adenocarcinoma (NOS)","Bladder Cancer","Gastrointestinal Stromal Tumour","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Renal Cell Carcinoma","Salivary Gland Cancer","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-06-26",{"date":91,"type":50},"2026-06-29",{"date":93,"type":50},"2025-09-18",{"date":95,"type":21},"2028-03-30",{"name":97,"class":98},"AstraZeneca","INDUSTRY",17,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100625624","phase-2-cthpvdna-response-adapted-chemoradiation---retifanlimab-treatment-in-locally-advanced-anal-cancer-100625624","NCT07425054","ctHPVDNA Response-Adapted Chemoradiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer","ctHPVDNA Adapted ChemoRadiation +\u002F- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)","CHART-AC","Inclusion Criteria:\n\n* Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Special considerations include the following:\n\n  * Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.\n* Age ≥18 years\n* ECOG performance status 0-2\n* Creatinine clearance \\>30 ml\u002Fmin by Cockcroft-Gault Equation.\n* HIV-infected participants are eligible if they meet the following eligibility criteria:\n\n  * A CD4 T-cell count \\>= 200\u002Fmm3 and a viral load \\\u003C 200 copies\u002Fmm3\n  * No history of AIDS-related complications within past year other than history of low CD4+ T-cell count (\\>200\u002Fmm3) prior to initiation of combination antiretroviral therapy.\n  * Participant must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.\n  * Participant MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks.\n  * Participants must be PPD negative. Alternatively, the QuantiFERON-TB assay can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off (after subtracting the background IFN-γ response in the negative control). The result must be obtained within 20 weeks prior to enrollment. PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.\n* Tumor size must be documented based on physical examination including digital rectal exam and\u002For anoscopy\u002Fproctoscopy within 4 weeks prior to enrollment.\n* Staging imaging studies must include a PET scan AND either a CT with contrast of the abdomen\u002Fpelvis or an MRI with contrast of the pelvis. It is preferred that participants receive contrast. For participants with an allergy who cannot receive pre-medication, or any other reason they can't receive IV contrast, it is recommended that they undergo an MRI of the pelvis.\n* Participant must have no history of prior chemotherapy for anal cancer.\n* Participant must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, participants who undergo local excision or excisional biopsy are eligible provided there was tumor involvement of the anal canal and\u002For anal verge prior to the resection, if the margins were positive, and\u002For if the stage is T2N0 based on tumor size before the procedure. This means that participants with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins and no involvement of the anal verge and\u002For anal canal are not eligible.\n* Participant must not be receiving any other standard anti-cancer therapy or experimental agent.\n* Participant must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric\u002Fsocial situations that, in the judgement of the investigator, would limit compliance with study requirements.\n* Participant must not have had significant cardiovascular disease within 6 months prior to enrollment that has not been treated\u002Fcontrolled in the opinion of the treating investigators including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia.\n* Participant must not have a history of a different malignancy unless they are deemed by the investigator to be at low risk of recurrence.\n* Participants who are on anti-coagulation with warfarin within 2 weeks prior to enrollment must use an alternative anti-coagulant if planned to receive Capecitabine, otherwise, they must receive infusional 5-FU.\n\n  * NOTE: Low molecular weight heparin is permitted provided the participant's PT\u002FINR is \\\u003C 1.5. Participants who will received capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked weekly.\n* Participants must have normal organ and marrow function as defined below:\n\n  * Hemoglobin ≥ 10.0 g\u002Fdl\n  * Platelet count ≥ 100,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Total bilirubin must be \\\u003C1.5 X institutional ULN OR conjugated bilirubin \\\u003C= institutional ULN if total bilirubin \\> 1.5 X ULN. Note that conjugated bilirubin only needs to be tested if total bilirubin \\>1.5 X ULN. Participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician.\n  * AST\u002FALT must be \\\u003C\u002F= 2.5 X institutional ULN (participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician).\n  * Albumin \\>\u002F= 3.0 g\u002FdL\n* Women must not be pregnant or breast-feeding because the study treatment may cause harm to an unborn fetus or breastfeeding child. A female of childbearing potential is defined as any woman, regardless of sexual orientation, or whether they have undergone a tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for at least six months after the completion of treatment.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have testing DPYD deficiency per institutional standards and must not be homozygous for DPYD deficiency.\n\nExclusion Criteria:\n\n* Any prior pelvic radiation or previous radiation that would result in overlapping radiation fields.\n* History of allergic reactions to compounds similar to capecitabine,\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator.\n* Participants with inflammatory bowel disease, scleroderma, or known homozygosity for DPYD deficiency.\n* Participants with a fistula between the tumor and invaded organ\n* Participant must not have active autoimmune disease or inflammatory bowel disease that has required systemic treatment in past 2 years\n* No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)\n* No participants with immunodeficiency or receiving systemic steroid therapy equivalent to \\> 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.\n* No live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.\n* Participants must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to retifanlimab.\n* Participants are excluded if known to be homozygous for Dihydropyrimidine Dehydronase",{"count":109,"type":21},33,[111],"PHASE2","This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT). CRT is when chemotherapy and radiation therapy are given at the same time. Studies show that CRT works well to treat anal cancer and prevents many people from needing surgery which may require a colostomy bag. Doctors know that CRT is an effective way to treat anal cancer. But, they are doing studies to find out how much dose of radiation and chemotherapy should be given during the CRT. Higher doses of chemotherapy and radiation could increase the risk of side effects, but lowering the dose of chemoradiation has the risk of not being as effective to treat the cancer. One way to predict whether participants need higher or lower doses of radiation therapy is to do a blood test called ctDNA (circulating tumor DNA) to test for the presence of human papillomavirus (HPV). This test is done at certain times while participants are getting CRT. This has been shown to be a marker for the presence of anal cancer.\n\nIn this study, doctors will tailor lower versus higher doses of CRT based on the tumor response that is measured by ctDNA. The purpose of this study is to see if customizing the dose of chemoradiation based on the amount of ctDNA will increase survival in participants with anal cancer and\u002For decrease the risk of side effects. Some participants in this study whose cancer does not respond as well to the CRT may have the opportunity to receive a drug called Retifanlimab that stimulates the body's immune system. Retifanlimab is approved by the Federal Drug Administration (FDA) for treating anal cancer that is recurrent or metastatic since there is proven benefit in these situations.",[28,114,115],"HPV-Related Carcinoma","Squamous Cell Carcinoma of the Anus",[117,118],"Chemoradiation","Retifanlimab","2026-06-25",{"date":89,"type":50},{"date":122,"type":21},"2026-06-19",{"date":124,"type":21},"2029-01",{"name":126,"class":57},"Jennifer Dorth",2,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":17,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":140,"studyType":70,"phases":4,"briefSummary":141,"conditions":142,"keywords":172,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":139,"type":21},999999,"80 Years","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[42,85,39,34,143,32,44,144,28,145,146,147,36,38,148,149,150,151,74,37,152,43,83,153,86,154,155,156,157,158,159,160,161,81,162,163,164,165,30,166,76,45,167,168,41,33,87,169,170,171],"Thymus Cancer","Gastrointestinal Stromal Tumors","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Penile Cancer","Ureter Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Leukemia","Unknown Primary Tumor","Multiple Myeloma","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[42,85,173,174,175,176,177,178,179,180,30,181,170,171],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":91,"type":50},{"date":184,"type":50},"2013-11-01",{"date":186,"type":21},"2099-12",{"name":188,"class":57},"University of Nebraska",42,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100643879","phase-1-coq10-and-vitamin-e-for-off-target-radiation-toxicity-100643879","NCT07668284","COQ10 and Vitamin E for Off-Target Radiation Toxicity","Evaluating the Safety and Efficacy of Coenzyme Q10 and Vitamin E Dual Therapy in Mitigating Chronic Off-Target Radiation Toxicity","Inclusion Criteria:\n\n1. Pathologically confirmed post-prostatectomy prostate, uterine (endometrial and cervical), or anal cancer.\n2. Scheduled for curative-intent, multi-fraction (at least 15 fractions) external-beam radiotherapy +\u002F- chemotherapy at the study site which does not involve re-irradiation to the same field.\n3. Age ≥ 19 years at the time of consent.\n4. Eastern Cooperative Oncology Group Performance Status ≤ 2.\n5. Life expectancy ≥ 6 months at the time of consent as determined by the participant's treating physician.\n6. Participants must be able to swallow soft-gel capsules.\n7. Participants must not have a disease significantly affecting drug absorption (e.g., resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction).\n8. Participants must agree to limit alcohol consumption to ≤ 2 standard drinks (14 g of pure ethanol) within 6 hours before and 6 hours after vitamin administration.\n9. Participants must agree to discontinue current vitamin\u002Fmineral supplements, including multivitamins, that contain Vitamin E (α-tocopherol) or CoQ10 (ubidecarenone) and abstain from taking these supplements while on study, including during the follow-up period. Participants must also agree to discontinue and abstain from high-dose vitamin\u002Fmineral supplementation while on-study and during the study follow-up period. NOTE: Participants for whom high-dose vitamin\u002Fmineral supplementation is medically necessary are eligible if the principal investigator determines that continuing treatment will not impact safety or study outcomes.\n10. Women of childbearing potential and male participants with partners of childbearing potential must agree to use two forms of medically effective contraception (at least one of which must be a barrier method) while on study until one month following the last dose of vitamin supplements.\n11. As determined by the enrolling physician, the participant must be able to understand and comply with study procedures for the entire length of the study. There must not be psychological, familial, sociological, or geographical conditions potentially hampering protocol compliance, including alcohol dependence or drug abuse.\n12. The participant or the participant's legally authorized representative must provide documented informed consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.\n13. Participant must have adequate hematological, organ, and clotting function as defined below. Screening labs must be obtained prior to the end of radiation therapy.\n\n    * Absolute Neutrophil Count (ANC) ≥ 500\u002Fmm3\n    * Platelets ≥ 50,000\u002Fmm3 • Hemoglobin ≥ 8.0 g\u002FdL. The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable.\n    * Calculated creatinine clearance (CrCl (mL\u002Fmin); Cockcroft-Gault formula) ≥ 30 mL\u002Fmin.\n    * Total bilirubin ≤ 1.5X institutional upper limit of normal (ULN) or ≤3 X ULN for patients with known Gilbert's syndrome\n    * AST (SGOT) and ALT (SGPT) ≤ 3X institutional ULN\n    * PT\u002FINR and PTT (in the absence of lupus anticoagulant) ≤ 2X institutional ULN.\n\nExclusion Criteria:\n\n1. Participants who do not receive ≥ 80% of the planned total radiation.\n2. Participants who are scheduled to receive SBRT\u002FSRS\n3. Participant's treatment plan must not include anti-cancer pharmaceutical therapies during the period of vitamin administration (\\~3 months after completion of radiation therapy).\n4. Participants must not receive any other investigational agents while on study.\n5. Participants must not have contraindications to Vitamin E or CoQ10 supplementation, including:\n\n   1. Anticoagulation or antiplatelet therapy that cannot be stopped. NOTE: To be eligible, participants must be able to discontinue contraindicated medications at least 2 weeks prior to the initiation of study treatment. These medications may be resumed 1 month after completing study treatment.\n   2. Underlying bleeding conditions (e.g., hemophilia or von Willebrand disease)\n   3. Retinitis pigmentosa\n   4. Hepatobiliary dysfunction\n   5. Vitamin K deficiency\n   6. Preexisting severe fibrosis\n   7. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage.\n   8. Uncontrolled Grade 2 hypertension defined as ≥ 140 mm Hg systolic blood pressure or ≥ 90 mm Hg diastolic blood pressure.\n   9. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).\n   10. Uncontrolled systemic bacterial, fungal, parasitic, mycobacterial, viral, or other infections, despite appropriate antibiotics or other treatments.\n   11. Any other uncontrolled comorbidities that, in the opinion of the treating investigator, would compromise subject safety or study outcomes.\n6. Participant must not have a history of allergic reactions to Vitamin E or CoQ10 or any of the vitamin excipients (soybean oil, soy lecithin, gelatin, glycerin).\n7. Not pregnant or lactating. A negative pregnancy test (serum hCG) is required for participants of childbearing potential. Female participants who are permanently sterilized (hysterectomy\u002Fbilateral oophorectomy) or postmenopausal (12 months of consecutive amenorrhea, \\> 45 years-of-age in the absence of other biological or physiological causes; females \\\u003C 55 years-of-age with serum FSH level \\> 40 mIU\u002FmL) are exempt",{"count":198,"type":21},200,[200,111],"PHASE1","The goal of this supportive care study is to learn if high-dose Vitamin E and CoQ10 in combination can reduce the negative sub-acute and chronic side effects of radiation to the pelvis in adults treated for prostate, uterine, cervical, or anal cancer.\n\nThe main questions it aims to answer are:\n\n* Is taking high doses of Vitamin E (dl-α-tocopherol acetate, 900mg) and CoQ10 (ubidecarenone, 200 mg) each day safe and tolerable?\n* Does a 90-day course of vitamin supplementation with high-dose Vitamin E and CoQ10 reduce the incidence and severity of late radiation-associated toxicities?\n* Does high-dose vitamin supplementation with Vitamin E and CoQ10 improve patient reported measure of quality of life?\n* Does high-dose vitamin supplementation with Vitamin E and CoQ10 change the trajectory of recovery after radiation therapy?\n* Is there evidence that suggests high-dose vitamin supplementation with Vitamin E and CoQ10 impairs oncologic outcomes?\n* Can longitudinal biomarkers of oxidative stress be correlated with Vitamin E and CoQ10 concentrations or radiation-associated toxicity?\n* Will subjects adhere to the vitamin administration schedule?\n* Are there demographic differences in systemic exposure to the vitamins?\n* Are there differences in toxicity outcomes across tumor types or radiation dose fractionation schemes?\n\nParticipants will be asked to:\n\n* Take Vitamin E and CoQ10 every day for 90 days by mouth.\n* Fill out quality of life questionnaires to assess treatment impacts.\n* Come for clinic visits every 2-4 weeks for around 4 months, then every 3-6 months for around 2 years.\n* Have blood draws more frequently than standard-of-care for clinical laboratory examinations and the collection of research samples.\n* Undergo Computed Tomography (CT) imaging of the chest, abdomen, and pelvis more frequently than standard of care.\n* Agree to lifestyle changes that ensure adequate vitamin absorption including intermittent abstinence from alcoholic beverages.",[43,203,31,28],"Uterine Cancer",[205,206,207,208],"radiation","toxicity","subacute","antioxidant","NOT_YET_RECRUITING",{"date":119,"type":50},{"date":47,"type":21},{"date":213,"type":21},"2030-12-15",{"name":188,"class":57},1,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":243,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983","NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as 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 as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. 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.\n11. 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.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. 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 transferase (AST) (SGOT)\u002Falanine 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.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants 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. 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.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. 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\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. 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.\n8. 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.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. 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.\n11. 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\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. 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.\n14. Current treatment with another investigational agent.",{"count":224,"type":21},20,[111],"This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[31,84,228,28,229,87,152,230,231,114,232,233,234,235,236,237,238,239,240,241,242],"Oropharynx Cancer","Vulva Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","2026-06-10",{"date":270,"type":50},"2026-06-12",{"date":272,"type":50},"2023-03-07",{"date":274,"type":21},"2027-01-01",{"name":276,"class":57},"Christian Hinrichs",3,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":127},"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":286,"type":21},15,[200,111],"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.",[290,114,231,235,234,237,233,239,240,241,238,31,228,28,88,152,87],"HPV-Associated Cervical Carcinoma",[253,292,293,294,295,117,296,245,256,248,297,298,299,300,301,302,303,304],"Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","CAR-T, cell therapy","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":270,"type":50},{"date":307,"type":50},"2025-08-11",{"date":309,"type":21},"2026-10-01",{"name":276,"class":57},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":135,"sex":319,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":4},"100556688","blood-biomarkers-based-screening-for-hpv-driven-opc-100556688","NCT06528353","Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV","Inclusion Criteria:\n\n* Aged ≥50 years from the general population\n* Man\n* No previous history of HPV-driven cancer or head neck cancer\n* Willingness to complete follow up visits\n\nExclusion Criteria:\n\n* Aged \\\u003C 50 years\n* Woman\n* History of HPV-driven cancer or head and neck cancer\n* Psychiatric conditions\n* Inability to complete follow up visits\n* Severe medical condition (life expectancy \\\u003C5 years)\n* Previous prophylactic HPV vaccination","MALE","50 Years",{"count":322,"type":21},10000,[24],"The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and\u002For whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.",[326,28,327],"Head and Neck Squamous Cell Carcinoma","Human Papilloma Virus",[329,330,331,332,333],"HPV-induced cancer","Head and Neck Cancers","virology","serology","secondary cancer prevention","2026-05-22",{"date":336,"type":50},"2026-05-26",{"date":338,"type":21},"2026-09",{"date":340,"type":21},"2032-09",{"name":342,"class":57},"UNICANCER",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":357,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":215},"100536304","equity-gi-a-prospective-study-to-enhance-quality-inclusivity-and-trial-participation-in-black-patients-with-gastrointestinal-cancer-100536304","NCT06263088","EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.","Inclusion Criteria:\n\n1. Adult ≥ 18 years old.\n2. Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer, appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor.\n3. Patient able and willing to comply with study procedures\n4. The patient is able to understand and willing to sign and date the written informed consent form at the screening visit.\n\nExclusion Criteria:\n\n* NONE",{"count":198,"type":21},[24],"This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).\n\nThis study has 3 components as follows-\n\n1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.\n2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.\n3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational\u002Finformational material appropriate for participant's diagnosis.",[353,32,44,28,34,354,355,356,38,169],"Gastrointestinal Cancer","Stomach Cancer","Appendix Cancer","Pancreas Cancer",[358,359],"Gastrointestinal cancer","African Americans","2026-05-19",{"date":334,"type":50},{"date":363,"type":50},"2024-12-01",{"date":365,"type":21},"2026-09-30",{"name":367,"class":57},"Case Comprehensive Cancer Center",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":135,"sex":17,"minAge":376,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":277},"100607707","self-sampling-to-optimize-anal-lesion-outcomes-100607707","NCT07192055","Self-sampling to Optimize Anal Lesion Outcomes","Self-sampling to Optimize Anal Lesion Outcomes (SOLO)","SOLO","A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study. Note that these criteria apply regardless of HPV vaccination status or disability status.\n\nInclusion Criteria:\n\n1. Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.\n2. Must be either:\n\n   1. A cisgender or transgender sexual minority man, or\n   2. A transgender woman who has sex with men.\n3. Resides in Chicago, Houston, or Milwaukee metropolitan area.\n4. Is willing to attend a study clinic.\n5. Speak and understand either English or Spanish\n6. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\nA potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Was a participant in the PAC Self-Swab Study in Milwaukee.\n2. Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.\n3. Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.\n4. Presence of any contraindicating severe disease or condition, e.g., anal stenosis.\n5. Plans to move within 12 months after enrollment.","35 Years",{"count":378,"type":21},572,[24],"The purpose of this research study is to find ways to increase anal cancer screening among people at increased risk for anal cancer. This study will try to find out if persons will do an intervention (self-sampling of the anal canal) and if it affects cytology and high-resolution anoscopy (HRA) appointment attendance. Secondarily, the study will assess if a person who gets their choice of either self-sampling or healthcare provider sampling affects clinic attendance.",[28],[262,252],"2026-05-11",{"date":385,"type":50},"2026-05-12",{"date":387,"type":50},"2025-11-18",{"date":389,"type":21},"2029-03-31",{"name":391,"class":57},"Medical College of Wisconsin",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":319,"minAge":376,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":409,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":422},"100595184","screening-for-anal-cancer-in-men-who-have-sex-with-men-using-pre-exposure-prophylaxis-100595184","NCT07029152","Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis","Screening for Anal Cancer in MSM Using PrEP","SCOPE","Inclusion Criteria:\n\n* HIV-uninfected MSM (men who have sex with men) aged 35 years or older.\n* participants must have been using PrEP for at least 3 months.\n* Dutch, English or French speaking and writing\n\nExclusion Criteria:\n\n* Any intervention in the (peri-)anal region within the past 3 months\n* Enema usage within 2 h before sampling\n* Currently undergoing peri-anal topical HPV-treatment\n* HRA in the last year (anal swab or HRA prior to the last year is no exclusion)",{"count":401,"type":21},296,[24],"This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Specifically, we want to check how common High-Grade Squamous Intraepithelial Lesions (HSIL) are in this group, how well anal swabs can screen for these lesions, and how having HSIL affects their quality of life. We'll also test if DNA methylation testing can give us extra information about the lesions.\n\nThe main questions the study aims to answer are:\n\n* How common are HSIL in MSM using PrEP?\n* How accurate are anal swabs for detecting HSIL in this group?\n* How does having HSIL affect the quality of life of MSM using PrEP?\n* Can DNA methylation testing help improve our understanding of HSIL in these individuals?\n\nParticipants will:\n\n* Answer questions about their health and quality of life.\n* Have an anal smear collected for testing.\n* Undergo High-Resolution Anoscopy (HRA) to check for HSIL and get a biopsy if deemed necessary.",[28,405,406,407,253,408],"Squamous Intraepithelial Lesions","HSIL, High Grade Squamous Intraepithelial Lesions","LSIL, Low-Grade Squamous Intraepithelial Lesions","Squamous Cell Carcinoma",[410,411,412,262],"HIV prevention","men who have sex with men","pre-exposure prophylaxis (PrEP)","2026-04-30",{"date":415,"type":50},"2026-05-01",{"date":417,"type":50},"2025-09-23",{"date":419,"type":21},"2026-12",{"name":421,"class":57},"Universitair Ziekenhuis Brussel",8,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":430,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":4},"100633166","assessment-of-sexual-quality-of-life-following-local-treatment-radiotherapy-with-or-without-surgery-in-patients-with-hpv-positive-pelvic-cancer-a-descriptive-longitudinal-study-100633166","NCT07523152","Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study","SAPPHIRE","Inclusion Criteria:\n\n1. Women aged 18 or over.\n2. Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis.\n3. Patients being treated at the Montpellier Cancer Institute (ICM).\n4. Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection\n5. Patient aware of her HPV status and how it is transmitted.\n6. Indicated for external radiotherapy\n7. Patient who has not received any oncological treatment prior to inclusion.\n8. Patient who has given verbal consent.\n\nExclusion Criteria:\n\n1. Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM).\n2. Patients who are unwilling or unable to complete the study questionnaires.\n3. Patients under guardianship, curatorship or court protection,\n4. Patients for whom regular follow-up is impossible for psychological reasons,\n5. Patients who do not speak French.","FEMALE",{"count":189,"type":21},[24],"In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life.\n\nHowever, few studies have examined the specific effect of HPV status (or knowledge of status) on the recovery\u002Fquality of sexuality following radiotherapy.\n\nIt is against this backdrop that we propose a prospective longitudinal study specifically dedicated to investigating the sexual quality of life of women with HPV-positive pelvic cancer.\n\nThis type of study will enable better quantification and description of sexual dysfunction occurring after treatment, and assessment of the impact of HPV carriage, with the future aim of guiding new prevention and management strategies.",[435,28,87],"Pelvic Cancer",[264,437,438],"uterus cancer","anal canal cancer","2026-04-04",{"date":441,"type":50},"2026-04-13",{"date":443,"type":21},"2026-04-02",{"date":445,"type":21},"2027-10-31",{"name":447,"class":57},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":469},"100553971","phase-2-study-of-pembrolizumab-carboplatin-paclitaxel-and-radiation-for-the-treatment-of-early-stage-anal-cancer-100553971","NCT06493019","Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer","A Phase II Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-1 within 30 days prior to registration.\n4. Histologically proven stage I (T1N0), IIA (T2N0), IIB (T1\u002F2N1), or IIIA (T3 N0\u002F1) invasive squamous cell carcinoma of the anus by AJCC version 9. Stage IIIB\u002FC (T4 N0\u002F1) cancers will also be eligible if less than 5cm in diameter.\n5. Patient deemed ineligible for standard of care treatment with 5-fluorouracil (5FU) and mitomycin-C (MMC) concurrently with radiation per treating investigator.\n6. Patient is treatment naïve for anal cancer diagnosis.\n7. Evaluable disease according to RECIST v1.1 within 30 days prior to registration.\n8. Archival or newly obtained tissue available for planned correlative analysis. If tissue is not available, subjects may choose to have a standard of care biopsy to meet eligibility.\n9. Demonstrate adequate organ function as defined below. All screening labs to be obtained within 30 days prior to registration.\n\n   * White blood cell (WBC) ≥ 1500 \u002Fmm\\^3\n   * Absolute Neutrophil Count (ANC) ≥ 1500\u002Fmm\\^3\n   * Hemoglobin (Hgb)a ≥ 9 g\u002FdL\n   * Platelets (Plt) ≥ 100,000 g\u002FdL\n   * Creatinine ≤ 1.5 × upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL\u002Fmin for creatinine levels \\>1.5 × institutional ULN\n   * Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n   * Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n   * Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n10. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration.\n11. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception.\n12. If a subject is HIV-infected, participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:\n\n    1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n    3. Participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n    4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. NOTE: HIV testing is not required for eligibility.\n13. If a subject has evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If a subject has a history of hepatitis C virus (HCV) infection, it must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.\n14. Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.\n\nExclusion Criteria:\n\n1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements.\n2. Has known additional malignancy that is progressing or has required active treatment within the past 2 years and is not deemed by the investigator to be at low risk for recurrence.\n\n   Notes: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (ex. cervical, breast) that have undergone potentially curative therapy are eligible. Participants with carcinoma in situ of the bladder are not eligible. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤8, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are eligible.\n3. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug(s). NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n4. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n5. Patients with an active autoimmune disease requiring immunosuppression in the past 2 years.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy equivalent to \\> 10mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to registration. NOTE: Topical corticosteroid or inhaled corticosteroids are allowed.\n7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to registration. Administration of killed vaccines is allowed. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid oral vaccine. Intranasal influenza vaccines (e.g., Flu-Mist ®) are live attenuated vaccines and are not allowed. NOTE: No live vaccines may be administered while participating in the trial.\n8. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n9. Has received any investigational drug or used an investigational device for the treatment of anal cancer within 30 days prior to registration.\n10. Has had an allogeneic bone marrow\u002Fstem cell or solid organ transplant.\n11. Has not adequately recovered from major surgery or has ongoing surgical complications.\n12. Has a history or current evidence of any condition, therapy, or 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.\n13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n14. Has had prior anti-PD1 immune checkpoint blockade.\n15. Is taking a contraindicated medication and is unable to discontinue or switch to an alternative medication within 7 days of initiating the study drugs.",{"count":456,"type":21},23,[111],"A single arm phase II study of pembrolizumab, carboplatin, paclitaxel, and radiation for the treatment of early-stage anal cancer. There are 2 treatments phases and then surveillance. The first treatment phase is the chemoradiation phase (Cycle 1-6, weekly cycles) which is followed by the maintenance phase (Cycle 7-14, 6 week cycles).",[28],"2026-03-19",{"date":462,"type":50},"2026-03-23",{"date":464,"type":50},"2024-09-30",{"date":466,"type":21},"2029-04-14",{"name":468,"class":57},"Dustin Deming",4,{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":430,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":215},"100369754","intrafractional-vaginal-dilation-in-anal-cancer-patients-undergoing-pelvic-radiotherapy-100369754","NCT04094454","Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy","Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study","DILANA","Inclusion Criteria:\n\n* Female patient\n* Histologically confirmed squamous anal cancer\n* Indication for definitive or postoperative radiotherapy\n* ECOG 0-2\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* patients refusal or incapability of informed consent\n* no vaginal dilatation possible prior to radiation treatment start\n* prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)\n* participation in another clinical trial which might influence the results of the DILANA trial\n* pregnancy\u002Fnursing period or inadequate contraception in women with child bearing potential",{"count":479,"type":21},60,[24],"A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \\\u003C20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \\>35-49% as Grade 3 and a reduction \\>\u002F=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.",[28],[484,485,486,487],"female patients","quality of life","vaginal dilator","vaginal fibrosis","2026-03-06",{"date":490,"type":50},"2026-03-10",{"date":492,"type":50},"2019-10-01",{"date":494,"type":21},"2027-04",{"name":496,"class":57},"Juergen Debus",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":127},"100428322","detecting-hpv-dna-in-anal-and-cervical-cancers-100428322","NCT04857528","Detecting HPV DNA in Anal and Cervical Cancers","Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy","Inclusion Criteria:\n\n* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.\n* Age ≥ 18 years\n* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy\n\nExclusion Criteria:\n\n* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the\n* Planned to undergo radiation therapy as an adjuvant or post-operative therapy",{"count":224,"type":21},"This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.",[31,28,239,232,114,507],"Uterine Cervical Cancer",[253,509,260,262,510],"radiation treatment","uterine cervix","2026-03-02",{"date":513,"type":50},"2026-03-04",{"date":515,"type":50},"2020-10-06",{"date":517,"type":21},"2027-11-15",{"name":519,"class":57},"University of Chicago",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":527,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":602,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":215},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":529,"type":21},360,[24],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[533,534,535,536,148,356,38,32,537,354,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,28,563,564,565,566,567,568,355,569,145,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,147,591,592,593,594,595,44,596,597,598,599,600,601],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Biliary Tract Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Ampullary Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[603,604,605,606,607],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":610,"type":50},"2026-02-20",{"date":612,"type":50},"2021-10-05",{"date":614,"type":21},"2027-03-16",{"name":616,"class":57},"Cedars-Sinai Medical Center",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":624,"targetDuration":626,"studyType":70,"phases":4,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":215},"100567615","hpv-genotype-attribution-and-disease-burden-of-anal-cancer-in-china-100567615","NCT06670495","HPV Genotype Attribution and Disease Burden of Anal Cancer in China","Understanding the Human Papillomavirus Genotype Attribution and Disease Burden of Anal Cancer in China: A Multicenter Hospital-based Study","Inclusion Criteria:\n\n* (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;\n\nExclusion Criteria:\n\n* (1) Patients with HIV infection, (2) Patients with immunosuppression after solid organ transplantation, (3) Those who do not agree to specimen collection and testing, (4) For retrospective study cases, those who without specimen.",{"count":625,"type":21},300,"1 Year","To demonstrate HPV prevalence and its genotype distributions in anal cancer in China and to describe demographic and clinical features of HPV-related anal cancer in China; To describe the epidemiological characteristics ,trends and of disease burden of anal cancer in China",[28],[630,631,300],"HPV prevalence","HPV genotype","2026-02-10",{"date":634,"type":50},"2026-02-12",{"date":636,"type":50},"2025-06-01",{"date":638,"type":21},"2028-12-31",{"name":640,"class":57},"Fudan University",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":430,"minAge":18,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":277},"100615717","beyond-survival-addressing-gynecological-and-sexual-health-in-women-after-radiotherapy-for-anal-cancer-100615717","NCT07296237","Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer","DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer","DACG VI","Inclusion Criteria:\n\n* Women aged 18 years or older\n* Diagnosed with anal cancer\n* Treated with chemoradiotherapy with curative intent\n* Between 6 and 36 months since completion of radiotherapy\n* Able and willing to give written informed consent\n\nExclusion Criteria:\n\n* Previous pelvic radiotherapy for another disease\n* Treated with electron beam radiotherapy\n* Unable to speak or understand Danish",{"count":650,"type":21},80,"The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems.\n\nThe main questions this study aims to answer are:\n\n* How many women develop moderate or severe narrowing of the vagina after radiotherapy?\n* Is there a link between the radiation dose and vaginal problems?\n* How do vaginal changes affect sexual health and daily life?\n* What care and support do women receive, and how satisfied are they with this support?\n\nParticipants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment.\n\nParticipants will:\n\nHave a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment\n\nThe study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study.\n\nThe results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.",[28],[262,654,655,656,657,658],"Radiotherapy","Sexual dysfunction","Female sexual health","Gynecological side effects","Patient-reported outcomes","2025-12-09",{"date":661,"type":50},"2025-12-22",{"date":663,"type":50},"2025-11-13",{"date":665,"type":21},"2026-09-01",{"name":667,"class":57},"Aarhus University Hospital",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":135,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":680,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":277},"100556219","identification-of-molecular-signatures-of-high-risk-oncogenic-hpv-and-study-of-their-associations-with-the-presence-of-high-grade-lesions-andor-anal-cancer-10-years-after-inclusion-in-the-anrs-ipergay-trial-100556219","NCT06522256","Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and\u002For Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial","HPVsign","Inclusion Criteria:\n\n* Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;\n* Informed and written signed consent\n* Participant with regular health insurance\n\nExclusion Criteria:\n\n* Participant under guardianship or curatorship\n* Participant with free State medical assistance\n* Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.",{"count":69,"type":21},[24],"HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and\u002For anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and\u002For diagnosed since the end of participation in the ANRS IPERGAY trial.",[679,28],"HPV Infection",[681],"HSIL","2025-11-27",{"date":684,"type":50},"2025-12-04",{"date":686,"type":50},"2025-03-20",{"date":688,"type":21},"2027-07-30",{"name":690,"class":691},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":697,"acronym":4,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":17,"minAge":699,"maxAge":700,"enrollmentInfo":701,"targetDuration":4,"studyType":22,"phases":703,"briefSummary":704,"conditions":705,"keywords":4,"overallStatus":209,"whyStopped":4,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":712,"completionDateStruct":714,"leadSponsor":716,"locationsCount":277},"100599875","phase-2-testing-for-safety-and-immune-effects-of-pds0101-an-anti-hpv-therapy-among-people-living-with-hiv-100599875","NCT07090174","Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV","A Single-Arm, Open-Label Clinical Phase II Trial of the Safety and Immunogenicity of PDS0101 in People Living With HIV","Inclusion Criteria:\n\n* HPV 16 detected on anal swab, cervical swab or vaginal swab ≤90 days of registration. (Note: HPV 16 detected on this swab can be from the screening evaluation or through standard of care assessments. The HPV 16 assay must be FDA-cleared and report HPV 16 results separately. The assay must be performed in a CLIA-certified laboratory.)\n* Cervical HSIL cohort: CIN III\u002Fcarcinoma in situ (CIS), CIN II\u002FIII, or CIN II with positive p16 stain diagnosed on cervical biopsy ≤90 days of registration and detection of cervical or vaginal HPV 16.\n* Cervical HSIL cohort: HSIL must occupy \\\u003C50% circumference of the cervical squamocolumnar junction, and adequate colposcopy with visualization of the endocervical HSIL margins. (Note: Participants with cervical HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction and\u002For inadequate visualization of the endocervical HSIL margins are not eligible for this protocol.)\n* Anal HSIL cohort: anal intraepithelial neoplasia (AIN) III, AIN II\u002FIII, or AIN II with positive p16 stain diagnosed on anal or perianal biopsy ≤90 days of registration and detection of anal HPV 16.\n* Anal HSIL cohort: HSIL must occupy \\\u003C50% circumference of the squamocolumnar junction. (Note: Participants with anal HSIL occupying ≥50% of the circumference of cervical squamocolumnar junction are not eligible for this protocol.)\n* Ages 25-65 years (i.e., no longer eligible on the 66th birthday).\n* HIV infection with receipt of antiretroviral therapy for at least 12 months.\n* CD4+ T-cell count ≥200 cells\u002Fmm3 ≤45 days of registration.\n* Plasma HIV-1 RNA \\\u003C200 copies\u002FmL ≤45 days of registration.\n* Participants must meet the following laboratory parameters ≤45 days before enrollment:\n\n  1. Absolute neutrophil count: ≥1,500\u002Fmm3\n  2. Platelets: ≥100,000\u002Fmm3\n  3. Hemoglobin \\>12.5 g\u002FdL for men and \\>11.5 g\u002FdL for women\n  4. Estimated glomerular filtration rate (eGFR) \\>70 mL\u002Fmin\u002F1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation or serum creatinine \\\u003C1.2 x upper limit of normal (ULN)\n  5. Aspartate aminotransferase (AST) (SGOT), and alanine aminotransferase (ALT) (SGPT), \\\u003C1.5 x ULN\n  6. Total bilirubin \\\u003C1.5 x ULN\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (or Karnofsky ≥70%).\n* Willingness to comply with three-dose immunotherapeutic agent schedule and subsequent study visits.\n* The effects of PDS0101 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for at least 120 days after the last dose of study treatment. Women of childbearing potential must have a negative urine pregnancy test (β-human chorionic gonadotropin) within 24 hours prior to registration and prior to visits on Days 1, 22, 43, 57, and 127. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately and will not receive any additional doses of immunotherapeutic agent. Women who become pregnant and partners of male participants who become pregnant will be followed to assess pregnancy outcomes.\n* Ability to understand and the willingness to sign a written informed consent form (ICF).\n\nExclusion Criteria:\n\n* AIDS-defining condition within 6 months prior to study entry.\n* Receipt of blood products within 6 months of enrollment or are currently taking immune suppressants.\n* History of HPV-related cancer or suspected cancer of the cervix, anus, vagina, vulva, penis, or oropharynx.\n* Current diagnosis of cancer or prior invasive cancer \\> T1 stage (other than non-melanoma skin cancer) that has required active treatment within the past 3 years.\n* Suspicion of invasive cancer of the cervix, vulva, vagina, perianus or anal canal. (Note: Concomitant vulvar, vaginal, or perianal HSIL is not exclusionary.)\n* Surgical or ablative treatment for anal or cervical HSIL within 180 days of study entry.\n* Prior receipt of any doses of a licensed or experimental HPV immunotherapeutic agent. (Note: Prior receipt of licensed prophylactic HPV vaccines is permitted.)\n* Planned use of intravaginal, vulvar, perianal or intra-anal imiquimod or 5-fluorouracil or another topical therapeutic agent with possible activity against HPV disease, or their use within ≤90 days of entry.\n* Receipt of a live vaccine within 30 days prior to the first dose of treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Coordination and timing of COVID-19 vaccination should be based on local Investigator clinical assessment and judgment.\n* Received immunotherapy\u002Fimmunomodulatory or immunosuppressive agents (e.g., IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers \\[GM-CSF, granulocyte-macrophage colony-stimulating factor\\]) within 6 weeks prior to administration of the first study treatment.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first dose of study treatment. (Note: Participants who entered the follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.)\n* Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Current or recent use of intra-articular, topical, or inhaled corticosteroids is acceptable.\n* Participants known to be positive for Hepatitis B antigen (HBsAg)\u002FHepatitis B virus (HBV) DNA or active Hepatitis C. Active Hepatitis C (HCV) is defined by a known positive HCV antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.\n* Plan to relocate during study period.\n* Acute medical conditions that would require exclusion from participation based on the opinion of the supervising physician.\n* Potential participants receiving any other investigational agents may be excluded in the opinion of the supervising physician.\n* Use of opioids within 2 weeks prior to enrollment. (Note: Medically assisted therapy for opioid use disorder or alcohol use disorder (e.g., stable methadone or buprenorphine\u002Fnaloxone) are not exclusionary. The rationale for excluding other opioid use is to allow appropriate grading of injection-related pain.)\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. Current bacterial sexually transmitted infection (STI) requiring treatment (participants may participate after adequate treatment, at the discretion of the treating provider).\n* Pregnant or breastfeeding, unwilling\u002Funable to use contraception, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of any study treatment.\n\n  a) For the purpose of this study, a WOCBP (i.e., fertile) is defined as the period following menarche and until becoming post-menopausal unless permanently sterile. Acceptable methods of birth control for this study include: i) Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\nii) A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\niii) Use of a barrier (diaphragm or condom) with spermicide iv) Combined hormonal (estrogen and progestogen) contraception associated with inhibition of ovulation v) An intrauterine device\u002Fsystem vi. An oral, transdermal, or injectable contraceptive vii. A vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.\n\nb) For the purpose of this study, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.\n\ni. Male participants must agree to use a condom as an effective method of contraception throughout the study and for at least 120 days after the last dose of study treatment.\n\n* Use of anticoagulants other than non-steroidal anti-inflammatory drugs or aspirin.","25 Years","65 Years",{"count":702,"type":21},27,[111],"This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Researchers will enroll 27 adults between the ages of 25 and 65 who have been receiving antiretroviral therapy (ART) for at least 12 months, have a cluster of differentiation 4 (CD4) cell count of at least 200 cells\u002Fmm³, and have an HIV viral load below 200 copies\u002FmL. All participants must have HPV 16 detected in the cervix, vagina, or anus. Some participants will have high-grade squamous intraepithelial lesions (HSIL), a condition that can lead to cancer. At least 10 participants will have cervical HSIL, and at least 10 will have anal HSIL. Participants with both cervical and anal HSIL will count in both groups. Others may have HPV 16 without HSIL.\n\nThis is a single-arm, open-label trial, which means that all participants will receive the same treatment, and both the investigators and the participants will know what the treatment is. Each participant will receive three doses of the PDS0101 vaccine. Participants who receive at least one dose will be included in the study's main safety analysis. If a participant does not receive all three doses and does not experience a serious side effect related to the vaccine (defined as a Grade 3 or higher toxicity), that participant may be replaced to make sure that 27 participants either complete the full vaccination schedule or experience a primary safety event. Participants who do have a qualifying safety event will not be replaced. Even if someone stops the study early, their data will still be included in the final analysis.\n\nThe main goals of this study are to evaluate the safety of PDS0101 and to measure the immune response it produces. The safety evaluation includes monitoring for serious or unexpected side effects, especially those that are Grade 3 or higher in severity. The immune response will be assessed by looking at how the body's T cells respond to HPV 16 after PDS0101 administration. The total time a participant is involved in the study includes the PDS0101 administration period and several follow-up visits, which may take place over the course of several months. This research may help inform future strategies for preventing or treating HPV-related disease in people living with HIV.",[706,707,28,31,708],"HPV Associated Cancers","HIV (Human Immunodeficiency Virus)","HPV 16 Infection","2025-09-25",{"date":711,"type":50},"2025-10-01",{"date":713,"type":21},"2025-10-20",{"date":715,"type":21},"2026-07-31",{"name":717,"class":57},"Weill Medical College of Cornell University",{"id":719,"slug":720,"hasResults":12,"nctId":721,"briefTitle":722,"officialTitle":722,"acronym":723,"eligibilityCriteria":724,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":725,"targetDuration":4,"studyType":22,"phases":727,"briefSummary":728,"conditions":729,"keywords":733,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":734,"lastUpdatePostDateStruct":735,"startDateStruct":737,"completionDateStruct":739,"leadSponsor":741,"locationsCount":277},"100359297","deciphering-mechanisms-underlying-cancer-immunogenicity-100359297","NCT03958240","Deciphering Mechanisms Underlying Cancer Immunogenicity","DECIDE","Inclusion Criteria:\n\n1. Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)\n2. Age ≥ 18 years at the time of study entry\n3. Patient followed within a standard of care procedure or clinical trial\n4. ECOG Performance status 0-2\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n6. Patient affiliated to a Social Health Insurance in France\n7. Patient may participate to other clinical trials\n\nExclusion Criteria:\n\n1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus\n2. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin \\\u003C 8g\u002Fdl)\n3. Patient pregnant, or breast-feeding\n4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n5. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship",{"count":726,"type":21},1100,[24],"This trial is a translational, open-label, multicentric, prospective cohort study of 1100 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.\n\nThe study will be conducted on a population of patients with local and\u002For metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.\n\nPatients with any of the following tumor types may be enrolled in the trial:\n\n* Head and neck cancer,\n* Ovarian cancer,\n* Cervical cancer,\n* Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),\n* Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)\n\nEach tumor type will be considered as an independent cohort.\n\nFor each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.\n\nStudy participation of each patient will be 5 years.",[40,41,31,730,731,732,28],"Cervical Intraepithelial Neoplasia 3","Glioblastoma Multiforme of Brain Stem","Non Small Cell Lung Cancer",[40,41,31,730,731,732,28],"2025-09-11",{"date":736,"type":50},"2025-09-15",{"date":738,"type":50},"2020-01-17",{"date":740,"type":21},"2033-01",{"name":742,"class":57},"Institut Claudius Regaud",{"id":744,"slug":745,"hasResults":12,"nctId":746,"briefTitle":747,"officialTitle":748,"acronym":749,"eligibilityCriteria":750,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":751,"targetDuration":4,"studyType":22,"phases":753,"briefSummary":755,"conditions":756,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":757,"lastUpdatePostDateStruct":758,"startDateStruct":760,"completionDateStruct":762,"leadSponsor":764,"locationsCount":766},"100532067","phase-3-phase-iii-study-evaluating-induction-chemotherapy-followed-by-chemoradiotherapy-compared-to-standard-chemoradiotherapy-for-locally-advanced-scca-100532067","NCT06207981","Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA","PRODIGE 85- KANALRAD : Prospective Randomized Phase III Study Evaluating Induction Chemotherapy (Modified DCF 4 Cycles) Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced Anal Squamous Cell Carcinoma (T3-4 or N1a, b or c)","KANALRAD","Inclusion Criteria:\n\n1. Anal Squamous cell carcinoma histologically proven\n2. Locally advanced tumors without metastases\n\n   * Stage T3 or T4\n   * Stage N1 (a, b or c) - any T (T1 to T4)\n3. Age ≥18 and ≤ 75 or \\> 75 in case of score G8 \\> 14 or favourable oncogeriatric assessment\n4. Measurable tumor on MRI\n5. Able to receive chemotherapy and radiotherapy\n6. No major comorbidity that may preclude the delivery of treatment\n7. Adequate hematologic function: absolute neutrophil count ≥ 1500\u002Fmm3, platelet count ≥ 100 000\u002Fmm3, Hb ≥ 9g\u002Fdl\n8. Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml\u002Fmin\n9. Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN\n10. WHO performance status \\\u003C 2\n11. Signature of informed consent\n12. A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a \"urine pregnancy test\", it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (Recommendations related to contraception and pregnancy testing in clinical trials)\n13. Female patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male (until 6 months after the end of the investigational treatments) and female patients of childbearing potential (until 7.5 months after the end of treatment with cisplatine)\n14. Patient to be covered by a regimen of French Social Security system.\n\nExclusion Criteria:\n\n1. Presence of metastases\n2. Stage T1N0 or T2N0\n3. History of pelvic radiotherapy\n4. Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng\u002FmL)\n5. Positive HIV serology with CD4 \\\u003C 400 \u002F mm3\n6. Presence of neuropathy \\> grade 2 according to NCIC-CTC 4.0\n7. Contraindication for chemotherapy and\u002For radiotherapy\n8. Concomitant treatment with CYP3A4 inhibitors or inducers\n9. Symptomatic cardiac or coronary insufficiency\n10. Progressive active infection or any unbalanced progressive severe condition in the last 6 months\n11. No contraindication to MRI imaging\n12. Other cancer treated within the last 3 years except in situ cervical carcinoma or basocellular\u002F spinocellular carcinoma or any other carcinoma in situ considered as cured\n13. breastfeeding woman.\n14. Persons deprived of liberty or under guardianship or incapable of giving consent\n15. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.\n16. Live attenuated vaccines within 4 weeks before randomization 17. In case of hearing problem 18. In case of combination with phenytoin with prophylactic aim 19. In case of recent or concomitant treatment brivudine",{"count":752,"type":21},310,[754],"PHASE3","Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer.\n\nthe efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerability, response rate and quality of life.\n\nThis trial will be offered to patients over 18 years of age with locally advanced anal cancer without metastasis (T3-4 or N1). It is open to patients over 75 years of age subject to a favorable evaluation by an oncogeriatrician. It is also open to immunocompromised patients (HIV+) if their immunity is well controlled under antiretroviral treatment.The standard chemoradiotherapy treatment consists of 33 sessions of radiation, one session per day from Monday to Friday for 6.5 weeks. It is combined with chemotherapy that includes mitomycin during the first and fifth weeks of radiation therapy, as well as capecitabine that are taken on the days of radiation therapy.In the experimental arm, this chemoradiotherapy treatment is preceded by 4 sessions of mDCF chemotherapy performed every 2 weeks.After treatment, patients are followed up at 8 weeks, then every 4 months for 2 years, and every 6 months for the last year with clinical examination and imaging (CT and MRI).",[28],"2025-08-29",{"date":759,"type":50},"2025-09-02",{"date":761,"type":50},"2024-02-26",{"date":763,"type":21},"2030-02-01",{"name":765,"class":57},"Federation Francophone de Cancerologie Digestive",114,{"id":768,"slug":769,"hasResults":12,"nctId":770,"briefTitle":771,"officialTitle":771,"acronym":772,"eligibilityCriteria":773,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":774,"enrollmentInfo":775,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":777,"conditions":778,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":779,"lastUpdatePostDateStruct":780,"startDateStruct":782,"completionDateStruct":784,"leadSponsor":786,"locationsCount":127},"100544281","stigma-and-psychological-profile-in-rectal-anal-cancer-patients-100544281","NCT06366841","Stigma and Psychological profilE in REctal-anal caNcer pAtients","SERENA","Inclusion Criteria:\n\nLocally advanced rectal and anal cancer patients undergoing a long course of radiotherapy\n\n* Patients in chemo-radiation treatment\n* Ability to understand and complete the questionnaires\n* Age ≥18 years\n* Informed consent signed\n\nExclusion Criteria:\n\n* Age \\> 75 years\n* Rectal and anal cancer patients undergoing short-course radiotherapy\n* Rectal and anal cancer patients undergoing palliative radiotherapy\n* Patients with inability to express informed consent\n* Patients denying informed consent\n* Patients with psychopathological disturbances preexisting to the cancer diagnosis\n* Patients affected by severe language deficits","75 Years",{"count":776,"type":21},148,"In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time.",[44,28],"2025-08-12",{"date":781,"type":50},"2025-08-15",{"date":783,"type":50},"2024-05-06",{"date":785,"type":21},"2026-08-31",{"name":787,"class":57},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":789,"slug":790,"hasResults":12,"nctId":791,"briefTitle":792,"officialTitle":793,"acronym":4,"eligibilityCriteria":794,"healthyVolunteers":135,"sex":319,"minAge":18,"maxAge":4,"enrollmentInfo":795,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":797,"conditions":798,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":799,"lastUpdatePostDateStruct":800,"startDateStruct":802,"completionDateStruct":804,"leadSponsor":806,"locationsCount":215},"100487523","assessing-the-gay-male-experience-with-anal-cancer-prevention-strategies-100487523","NCT05628194","ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES","SAVE THE BOTTOMS!!!: ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES","Inclusion Criteria:\n\n* ≥18 years of age\n* Current resident of the U.S.\n* Engage in anoreceptive intercourse with male partners\n* Fluent in English or Spanish\n\nExclusion Criteria:\n\n* Under the age of 18 years old\n* Not living in the United States\n* Not born with sex assigned at birth as male\n* Does not engage in sex with male partners",{"count":796,"type":21},5000,"The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.",[28],"2025-08-01",{"date":801,"type":50},"2025-08-03",{"date":803,"type":50},"2023-06-08",{"date":805,"type":21},"2026-06-30",{"name":807,"class":57},"University of Minnesota",{"id":809,"slug":810,"hasResults":12,"nctId":811,"briefTitle":812,"officialTitle":812,"acronym":813,"eligibilityCriteria":814,"healthyVolunteers":135,"sex":430,"minAge":815,"maxAge":4,"enrollmentInfo":816,"targetDuration":4,"studyType":22,"phases":818,"briefSummary":819,"conditions":820,"keywords":824,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":825,"lastUpdatePostDateStruct":826,"startDateStruct":828,"completionDateStruct":830,"leadSponsor":832,"locationsCount":215},"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":817,"type":21},110,[24],"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.",[88,31,821,822,28,823,239],"Vulvar Dysplasia","Cervical Dysplasia","Anal Dysplasia",[88,31,821,822,28,823,253],"2025-05-13",{"date":827,"type":50},"2025-05-16",{"date":829,"type":50},"2021-02-01",{"date":831,"type":21},"2026-01-01",{"name":833,"class":57},"Dr. Danielle Vicus"]