[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547103":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":24,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"active surveillance",null,"wait-and-see strategy",{"label":13,"type":10,"description":14,"interventionNames":10},"immediate treatment","surgical treatment per clinical practice",[16],{"name":17,"affiliation":5,"role":18},"Anna Daniela Iacobone","PRINCIPAL_INVESTIGATOR",[20],{"name":17,"role":21,"phone":22,"phoneExt":10,"email":23},"CONTACT","+39 0294371088","annadaniela.iacobone@ieo.it",[25,41],{"facility":26,"status":27,"city":28,"state":10,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"European Institute of Oncology, Milan,","RECRUITING","Milan","20141","Italy","IT",{"type":33,"coordinates":34},"Point",[35,36],9.18951,45.46427,{"lat":36,"lon":35},[39],{"name":40,"role":21,"phone":22,"phoneExt":10,"email":23},"ANNA DANIELA IACOBONE",{"facility":5,"status":42,"city":28,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":43,"geoPoint":45,"contacts":46},"NOT_YET_RECRUITING",{"type":33,"coordinates":44},[35,36],{"lat":36,"lon":35},[47],{"name":17,"role":21,"phone":10,"phoneExt":10,"email":10},{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100547103","evaluation-of-the-precursor-m-in-cin2-100547103",false,"NCT06403618","Evaluation of the PreCursor-M+® in CIN2","Evaluation of the PreCursor-M+® Assay Performance in the Management of Women Diagnosed With CIN2","Inclusion Criteria:\n\n1. age at diagnosis of 18 years or older;\n2. histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization;\n3. known HPV test result at baseline;\n4. ability to understand and sign the informed consent;\n5. written informed consent given.\n\nExclusion criteria:\n\n1. unknown HPV test result at diagnosis;\n2. vulnerable patients.","FEMALE","18 Years",{"count":60,"type":61},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to to evaluate the accuracy and sensitivity of PreCursor-M+ on a post-aliquot of liquid-based cytology (LBC) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of CIN2.\n\nThe PreCursor-M+® assay is a multiplex real-time methylation specific PCR test that identifies the level of promotor methylation of the host cell genes FAM19A4 and miR124-2, known biomarkers associated with cervical carcinoma and transforming CIN in cervical cells.\n\nTo evaluate the clinical course of CIN2 at 2 years after the first diagnosis, with an interval evaluation at 6 months.\n\nAfter enrolment, women will be divided into two groups: \"active surveillance\" and \"immediate treatment\". In the first group, clinical outcomes to be assessed, in relation to the PreCursor-M+ result at baseline, will include regression to \\\u003CCIN2, persistence of CIN2, and progression to CIN3+. In the second group, we will evaluate the histological diagnosis at cone specimen (downgrading or upgrading) and the 2-year cumulative incidence of CIN2+ recurrence based on the PreCursor-M+ result at baseline.",[65],"Cervical Intraepithelial Neoplasia Grade 2","2025-05-20",{"date":68,"type":69},"2025-05-23","ACTUAL",{"date":71,"type":69},"2024-06-17",{"date":73,"type":61},"2027-06-17",{"name":5,"class":6},2]