[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541262":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":24,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Case patients",null,"Histological-confirmed high-grade anal intraepithelial neoplasia (AIN2+ and 3+) and invasive cancer; patients with macroscopic anal lesion.",{"label":13,"type":10,"description":14,"interventionNames":10},"Control patients","Histological-confirmed low-grade anal intraepithelial neoplasia (AIN1), and subjects at high-risk for anal cancers, including: Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation); Men who have sex with men (MSM); Women aged at least 40 years with a history of CIN2+ and\u002For vulvar cancer; Subjects affected by anal and\u002For peri-anal localizations of Crohn's disease.",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Fabio Bottari","CONTACT","+390294372716","fabio.bottari@ieo.it",{"name":22,"role":18,"phone":10,"phoneExt":10,"email":23},"Cristina Mazzon","cristina.mazzon@ieo.it",[25],{"facility":5,"status":26,"city":27,"state":10,"zip":10,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"RECRUITING","Milan","Italy","IT",{"type":31,"coordinates":32},"Point",[33,34],9.18951,45.46427,{"lat":34,"lon":33},[37,38,41],{"name":17,"role":18,"phone":10,"phoneExt":10,"email":10},{"name":39,"role":40,"phone":10,"phoneExt":10,"email":10},"Cristina Trovato, MD","SUB_INVESTIGATOR",{"name":42,"role":40,"phone":10,"phoneExt":10,"email":10},"Anna Daniela Iacobone, MD",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100541262","anal-cancer-andor-precancer-screening-performance-analysis-of-the-bd-onclarity-hpv-assay-on-anal-specimens-100541262",false,"NCT06327568","Anal Cancer and\u002For Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens","Anal Cancer and\u002For Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens","Inclusion Criteria:\n\n* Subjects older than 18 years old\n* Subjects with histological-confirmed high-grade anal intraepithelial neoplasia (AIN2+) or anal invasive cancer\n* Subjects with histological-confirmed low-grade anal intraepithelial neoplasia (AIN1)\n* Subjects at high-risk for anal cancers, including:\n\n  1. Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation)\n  2. Men who have sex with men (MSM)\n  3. Women aged at least 40 years with a history of cervical intraepithelial neoplasia CIN2+ and\u002For vulvar cancer\n  4. Subjects affected by anal and\u002For peri-anal localizations of Crohn's disease\n* Subjects undergoing colorectal cancer screening\n* Signed written consent.\n\nExclusion Criteria:\n\n* Refuse to sign written consent.","ALL","18 Years",{"count":55,"type":56},200,"ESTIMATED","OBSERVATIONAL","Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.\n\nThe diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.\n\nThe performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach.",[60,61,62,63],"Anal Intraepithelial Neoplasia 2","Anal Intraepithelial Neoplasia 1","Anal Cancer","High-Risk Cancer",[65,66,67,68],"anal cancer","Human papillomavirus (HPV) infection","PCR genotyping","AIN 2","2024-03-22",{"date":71,"type":72},"2024-03-26","ACTUAL",{"date":74,"type":72},"2022-06-17",{"date":76,"type":56},"2029-06-17",{"name":5,"class":6},1]