[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anal-hsil\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anal-hsil":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100589083","phase-2-cascade-2002-protect-study-probiotics-to-treat-anal-precancer-trial-100589083",false,"NCT06949800","CASCADE 2002: PROTECT Study, \"PRObiotics to TrEat Anal preCancer Trial","Probiotics to Treat HSIL and Reduce Persistent High Risk HPV Infection in Women and Men Living With HIV","Inclusion Criteria:\n\n1. Signed informed consent\n2. Participant in ULACNet-101 or participant screened specifically for ULACNet-102.\n3. Biopsy-proven anal HSIL (men or women) shown as part of participation in the ULACNet-101 study or at a screening visit for ULACNet-102.\n4. At least one focus of anal HSIL must be large enough to be monitored for response, i.e.,not completely removed after the screening biopsy.\n5. Total volume of HSIL is less than 50% of the anal canal or perianal region.\n6. Must be actively on treatment with effective antiretroviral therapy (ART) regimen for at least three months preceding enrollment (Visit 1, Day 1) in ULACNet-101 or at screening for ULACNet-102.\n7. HIV RNA \\\u003C200 copies\u002Fml at baseline.\n8. Cluster of differentiation 4 (CD4) nadir above 200 cells per microliter (uL)\n9. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1 (Karnofsky \\>= 70%).\n10. Participants must meet the following laboratory parameters within 3 months before enrollment:\n\n    1. Leukocytes: ≥3,000\u002Fmm\\^3.\n    2. Absolute neutrophil count: ≥1,500\u002Fmm\\^3.\n    3. Platelets: ≥100,000\u002Fmm\\^3.\n    4. Elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin \\\u003C2 times the upper limit of normal.\n11. Not pregnant or breast feeding and one of the following:\n\n    1. Of non-childbearing potential (i.e. persons aged 60 years or older or who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative medical cause).\n    2. Persons aged less than 60 years of childbearing potential and agree to practice highly effective contraception from initiation of taking EXE-346 or placebo through 14 days after taking the last dose of EXE-346 or placebo. Highly effective methods of contraception include one or more of the following:\n\n    i.Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant.\n\nii.Hormonal (oral, intravaginal, transdermal, implantable or injectable); Progestogen-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective.\n\niii. An intrauterine hormone-releasing system. iv. An intrauterine device. v. Bilateral tubal occlusion or removal. vi. Sexual abstinence, only if the participant refrains from heterosexual intercourse from initiation taking EXE-346 or placebo through 14 days after taking the last dose of EXE-346 or placebo and it is the usual lifestyle of the participant.\n\nExclusion Criteria:\n\n1. History of any anogenital cancer.\n2. Presence of untreated cervical HSIL or cervical cancer.\n3. Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.\n4. Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit for ULACNet-102.\n5. Immunosuppression as a result of underlying illness or treatment including:\n\n   1. Use of high dose corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for \\>=7 days (inhaled, otic, topical and ophthalmic corticosteroids are permitted).\n   2. Primary immune deficiency disease.\n   3. Use of synthetic or biologic disease-modifying anti-rheumatic drugs.\n   4. History of bone marrow or solid organ transplant.\n   5. History of any other clinically significant autoimmune or immunosuppressive disease.\n6. Participant initiated a new treatment with antibiotics within the 2 weeks prior to screening or plans to start antibiotic therapy during the study period.\n7. Participant is taking NSAIDs as a long-term treatment (ie, consistent use for at least 4 days\u002Fweek each month). Acute use of NSAIDs is allowed.\n8. Participant has known hypersensitivity to EXE-346 or any product components.\n9. Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n10. Warts so extensive that they preclude the clinician from determining the extent and location of HSIL.\n11. Sustained, manually confirmed, sitting systolic blood pressure \\>150 mm Hg or \\\u003C90 mm Hg or a diastolic blood pressure \\>95 mm Hg as measured by 3 readings taken 15 minutes apart at screening or Visit 1.\n12. History of significant thrombocytopenia, history of thrombosis with thrombocytopenia (TTS) syndrome or heparin-induced thrombocytopenia.\n13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.\n14. Participant has participated in any clinical study of an approved or unapproved investigational medicinal product within the 30 days prior to screening.\n15. Any other finding that, in the opinion of the Investigator deems the participant unsuitable for the study","ALL","21 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population",[26,27,28],"HSIL, High Grade Squamous Intraepithelial Lesion","HPV-Related Squamous Cell Carcinoma","Anal HSIL",[30,31,32],"HIV","Anal intraepithelial neoplasia (AIN) 3","p16+ AIN 2","NOT_YET_RECRUITING","2026-04-29",{"date":36,"type":37},"2026-05-01","ACTUAL",{"date":39,"type":20},"2026-06-01",{"date":41,"type":20},"2027-05-31",{"name":43,"class":44},"University of California, San Francisco","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100602442","anal-cancer-prevention-in-high-risk-categories-of-men-who-have-sex-with-men-100602442","NCT07123558","Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men","Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men - A Danish Prospective Study","DACaP","Inclusion Criteria:\n\n* MSM with HIV\n* HIV-negative MSMonPrEP\n* Age \\>=35 years\n* Written and orally informed consent in English or Danish\n\nExclusion criteria\n\n* Previous anal cancer\n* Rectum extirpation (of any cause)\n* Unwilling to have HRA performed\n* Inflammatory bowel disease\n* Inability and unwillingness to give informed consent\n* Other known immunosuppressive disorder than HIV\n* No sex with men",true,"MALE","35 Years",{"count":58,"type":20},700,[60],"NA","The incidence of anal cancer is increasing, particularly among high-risk groups such as men who have sex with men (MSM), especially those living with HIV. The lack of comprehensive screening programs results in delayed diagnosis and higher mortality.\n\nThis project aims to establish a screening program for anal cancer in high-risk populations, with a specific focus on those most at risk. Using a prospective study design, the project will assess the effectiveness of early detection and prevention strategies to potentially reduce cancer incidence and improve survival rates. If an HPV-based screening method proves effective, it would serve as a potential implemention for high-risk groups in Denmark, further enhancing early detection and prevention efforts.\n\nThis study represents the first large-scale, prospective screening initiative for anal cancer in Denmark,specifically targeting MSM. It introduces a novel approach to cancer prevention in this population by building on research in other cancers and adapting it to anal cancer and its specific risk factors.\n\nThe project is a collaboration between clinical practitioners and academic researchers, ensuring that practical clinical insights guide the research and that research findings are rapidly translated into clinical practice. This partnership will enhance both the quality of the research and its direct application in healthcare.\n\nThe project is expected to lead to earlier diagnosis of anal cancer, reduced morbidity and mortality among high-risk populations, and the establishment of a screening model that can be applied nationwide. This could significantly reduce the overall healthcare burden associated with late-stage anal cancer and improve patient outcomes across Denmark.",[28,63,64],"Anal AIN3","Anal HPV Infection",[66,67,68,69],"anal HSIL","HIV infection","MSM","anal HPV infection","2025-08-13",{"date":72,"type":37},"2025-08-14",{"date":74,"type":20},"2025-11-01",{"date":76,"type":20},"2027-10-31",{"name":78,"class":44},"Bispebjerg Hospital",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":45},"100531958","phase-2-artesunate-ointment-for-the-treatment-of-anal-hsil-in-hiv-negative-participants-100531958","NCT06206564","Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants","A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)","ART-AIN IIB-2","Inclusion Criteria:\n\n* Adult men and women age ≥ 18 years\n* Capable of informed consent\n* Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.\n* Positive anal human papillomavirus (HPV) test.\n* Women of childbearing potential agree to use birth control for the duration of the study.\n* Laboratory values at Screening of:\n\n  1. Serum alanine transaminase (SGPT\u002FALT) \\\u003C 5 x upper limit of normal (ULN)\n  2. Serum aspartate transaminase (SGOT\u002FAST) \\\u003C 5 x ULN\n  3. Serum Bilirubin (total) \\\u003C 2.5 x ULN\n  4. Serum Creatinine ≤ 1.5 x ULN\n* Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA\n* Concurrent anal, vulvar, cervical, or penile cancer\n* HIV-seropositivity\n* Currently receiving systemic chemotherapy or radiation therapy for another cancer.\n* Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.\n* Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors\n* Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study","18 Years",{"count":89,"type":20},48,[23],"This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)",[93,28,64,94],"Anal High-grade Squamous Intraepithelial Lesion","AIN",[96,97,98],"intra-anal","topical","non-surgical","RECRUITING","2025-05-14",{"date":102,"type":37},"2025-05-18",{"date":104,"type":37},"2024-01-12",{"date":106,"type":20},"2026-12-31",{"name":108,"class":109},"Frantz Viral Therapeutics, LLC","INDUSTRY"]