[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anal-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anal-dysplasia":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100290490","screening-for-anal-cancer-in-women-with-high-grade-vulvar-dysplasia-or-vulvar-cancer-100290490",false,"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",true,"FEMALE","40 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33],"Vulvar Cancer","Cervical Cancer","Vulvar Dysplasia","Cervical Dysplasia","Anal Cancer","Anal Dysplasia","HPV-Related Anal Squamous Cell Carcinoma",[27,28,29,30,31,32,35],"HPV","RECRUITING","2025-05-13",{"date":39,"type":40},"2025-05-16","ACTUAL",{"date":42,"type":40},"2021-02-01",{"date":44,"type":21},"2026-01-01",{"name":46,"class":47},"Dr. Danielle Vicus","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100564105","phase-2-evaluating-gardasil-hpv-vaccine-humoral-and-cellular-immune-responses-in-people-with-and-without-hiv-100564105","NCT06624839","Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV","A PRe-pOsT Interventional Study Evaluating Gardasil Nine-valent Human Papilloma Virus (HPV) Vaccine Humoral and Cellular Immune Responses in People With or Without HIV","PROTECT","Inclusion Criteria:\n\n* 18 years old or older and 70 years old or younger\n* Able to provide informed consent\n* Denies history of prior HPV vaccination with Gardasil9 (receipt of HPV vaccination other than Gardasil9 such as the bivalent or the quadrivalent HPV vaccine will be allowed) or unsure of vaccination status and born before 2003\n* Born Male\n\nFor Test group: HIV-positive people born male with current or past exposure to androgen blockers or estrogen (BM-EABE)\n\n* Living with HIV\n* Current or past exposure to androgen blockers or estradiol\n\nFor Control group: HIV-negative Control\n\n* HIV negative\n* Either: Current or past exposure to androgen blockers or estradiol; no current or past exposure to androgen blockers or estradiol AND had sex with a person with a penis in the last year\n\nExclusion Criteria:\n\n* Younger than 18 years old or older than 70 years old.\n* Self-reported or documented history of nine-valent HPV vaccine or unsure of vaccination status and born after 2003.\n* Born female\n* History of hypersensitivity, including severe reactions to yeast or other component of the vaccine.\n* Any condition requiring systemic chemotherapy or immunomodulant affecting antibody responses (i.e., rituximab, ibrutinib etc.), intravenous or subcutaneous immunoglobulin supplementation, radiation therapy, or immunomodulatory treatment within the previous 6 months (presence of precancerous lesions is not exclusionary).","MALE","18 Years","70 Years",{"count":61,"type":21},120,[63],"PHASE2","This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).",[66,32,67],"Human Papilloma Virus","HIV","2025-04-30",{"date":70,"type":40},"2025-05-04",{"date":72,"type":40},"2025-03-15",{"date":74,"type":21},"2028-01",{"name":76,"class":47},"University of Maryland, Baltimore"]