[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05217940":3,"trial-entities:NCT05217940":152,"trial-summary:NCT05217940":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":43,"secondary_outcomes":48,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":95,"locations":98,"central_contacts":139,"overall_officials":144,"references":150,"see_also_links":151},"NCT05217940","GCO 20-0309","Screening Women With Prior HPV for Anal Neoplasia","The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors","RECRUITING","2027-01","2025-08","2025-08-22","2022-03-02","Icahn School of Medicine at Mount Sinai","OTHER",false,"The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.","This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.",[19,20,21],"HPV-related Lower Genital Tract Neoplasias","HPV-related Anal Neoplasias","Early Stage Lower Genital Tract Cancers",[23,24,25,26,27,28],"anal cancer","anal precancerous","anal high grade intraepithelial lesion","anal cytology","high resolution anoscopy","anal human papilloma virus testing","INTERVENTIONAL","SCREENING",[32],"NA",{"count":34,"type":35},300,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DIAGNOSTIC_TEST","Diagnostic tests for anal cancer screening","The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.",[42],"Women With Prior HPV for Anal Neoplasia",[44],{"measure":45,"description":46,"timeFrame":47},"Sensitivity and specificity of anal cytology","Test sensitivity and specificity","Baseline",[49,53,56,59,61,63,65,66,67,70,73,76,79,80,82],{"measure":50,"description":51,"timeFrame":52},"Concordance of self- and clinician-collected PCR testing","Proportionate concordance of high-risk HPV testing","baseline",{"measure":54,"description":55,"timeFrame":47},"Prevalence of hrHPV types at baseline","Proportion of subjects with high-risk HPV and subtype proportions",{"measure":57,"description":58,"timeFrame":47},"hrHPV with Cobas PCR testing (self-collected)","Presence of high-risk HPV subtype",{"measure":57,"description":58,"timeFrame":60},"12 months",{"measure":57,"description":58,"timeFrame":62},"24 months",{"measure":64,"description":58,"timeFrame":47},"hrHPV with Cobas PCR testing (clinician-collected)",{"measure":64,"description":58,"timeFrame":60},{"measure":64,"description":58,"timeFrame":62},{"measure":68,"description":69,"timeFrame":47},"Prevalence of aHSIL at baseline","Proportion of subjects with aHSIL",{"measure":71,"description":72,"timeFrame":62},"Incidence of aHSIL at follow-up","Proportion of subjects with new aHSIL during follow-up period",{"measure":74,"description":75,"timeFrame":47},"Screening Experience Survey","Survey measures anal cancer screening test acceptability. Each item is scored 0-3, with higher score indicting more acceptability. 0-3. There is no total scale. Each question is scored separately and the overall results are used qualitatively.",{"measure":77,"description":78,"timeFrame":60},"Incidence of hrHPV, by type","Proportion of subjects with new hrHPV infection",{"measure":77,"description":78,"timeFrame":62},{"measure":78,"description":81,"timeFrame":60},"Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up",{"measure":78,"description":81,"timeFrame":62},"FEMALE","35 Years",null,{"inclusion":87,"exclusion":93,"raw_text":94},[88,89,90,91,92],"Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)","Documented HIV seronegativity","Aged 35 years and older","Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston","English or Spanish speaking",[],"Inclusion Criteria:\n\n* Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)\n* Documented HIV seronegativity\n* Aged 35 years and older\n* Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston\n* English or Spanish speaking\n\nExclusion Criteria:\n\n• prior history or high resolution anoscopy",[96,97],"ADULT","OLDER_ADULT",[99,114,125],{"facility":13,"status":8,"city":100,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":111},"New York","10029","United States",[104,108],{"name":105,"role":106,"email":107},"Nadia M Zubair, MPH","CONTACT","nadia.zubair@mountsinai.org",{"name":109,"role":110},"Keith Sigel, MD PHD MPH","PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},40.71427,-74.00597,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":102,"contacts":119,"geoPoint":122},"Medical University of South Carolina","Charleston","South Carolina","29425",[120],{"name":121,"role":110},"Ashish Deshmukh, PhD",{"lat":123,"lon":124},32.77632,-79.93275,{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":102,"contacts":130,"geoPoint":136},"University of Texas M D Anderson Cancer Center","Houston","Texas","77030",[131,134],{"name":132,"role":106,"email":133},"Elizabeth Chiao","EYChiao@mdanderson.org",{"name":135,"role":110},"Elizabeth Chiao, MD",{"lat":137,"lon":138},29.76328,-95.36327,[140],{"name":141,"role":106,"phone":142,"email":143},"Daniela Solis","305-775-2140","daniela.solis@mountsinai.org",[145,147,149],{"name":146,"affiliation":13,"role":110},"Keith Sigel, MD, PhD, MPH",{"name":135,"affiliation":148,"role":110},"M.D. Anderson Cancer Center",{"name":121,"affiliation":115,"role":110},[],[],{"nct_id":4,"conditions":153,"biomarkers":162},[154,155,156,157,158,159,160,161],"Anal Carcinoma","Anal Intraepithelial Neoplasia","Cervical Carcinoma","Cervical Intraepithelial Neoplasia","Vaginal Carcinoma","Vaginal Intraepithelial Neoplasia","Vulvar Carcinoma","Vulvar Intraepithelial Neoplasia",[],{"nct_id":4,"found":164,"summary":165,"prompt_version":175},true,{"design":166,"status":167,"heading":168,"summary":169,"follow_up":170,"word_count":171,"commitments":172,"compensation":173,"drugs_mentioned":174},"This is a single-arm study, meaning all 300 participants will receive the same diagnostic tests. It is an interventional study, focusing on diagnostic tests for anal cancer screening.","completed","Screening for Anal Cancer in Women with Prior HPV-Related Conditions","This study is looking at different ways to screen for anal cancer in women who have had certain HPV-related conditions (like cervical, vulvar, or vaginal pre-cancers or early cancers). Researchers want to see how well tests like anal cytology (a 'Pap test' for the anus) and HPV testing work to find early signs of anal cancer. They will also perform a digital rectal exam. You might be able to join if you are a woman aged 35 or older, have a history of high-grade HPV-related disease in your lower genital tract, and do not have HIV. The main goal is to find out how accurate these screening methods are. The study is currently unclear on its status and plans to enroll 300 participants.","Participants will be followed for 24 months after their initial evaluation.",123,"You would have an initial visit for diagnostic tests, including anal cytology, self-collected and clinician-collected HPV specimens, and a digital rectal exam. You would then have follow-up evaluations at 12 and 24 months.","Not stated in the trial record.",[],"v2"]