[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635232":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":37,"locations":43,"responsibleParty":69,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":23,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":23,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy","EXPERIMENTAL","Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. Management is based on HPV genotype within a predefined test-triage-treat strategy:\n\n* Women positive for HPV16 receive immediate treatment with thermal ablation.\n* Women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo triage with digital telecytology. If cytology results are abnormal (≥ ASC-US), treatment with thermal ablation is provided.\n* Women positive for HPV types 51, 59, 39, 56, 66, or 68 are managed with follow-up at 12 months without immediate treatment.\n\nAll HPV-positive women undergo endocervical sampling and biopsy, as the reference standard for diagnostic evaluation.",[13,14,15,16],"Diagnostic Test: HPV testing (self-sampling)","Diagnostic Test: Digital telecytology","Diagnostic Test: AI-assisted telecytology","Procedure: Thermal ablation",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","HPV testing (self-sampling)","HPV testing performed on self-collected vaginal samples providing extended genotyping for high-risk HPV types.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Digital telecytology","Digital cytology performed on HPV-positive women, including slide preparation, digitization, and remote interpretation by trained cytology experts for the detection of cytological abnormalities (≥ ASC-US).",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"AI-assisted telecytology","Artificial intelligence-assisted analysis of digital cytology images to support detection of cervical abnormalities in HPV-positive women.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"PROCEDURE","Thermal ablation","Thermal ablation is used for treatment of women who are HPV16-positive, as well as for women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 who have abnormal cytology results (≥ ASC-US).",[9],[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Patrick Petignat, Doctor; Professor","CONTACT","+41 22 37 24 432","patrick.petignat@hug.ch",[44,61],{"facility":45,"status":46,"city":47,"state":23,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Centre Hospitalier Universitaire de Yaoundé","RECRUITING","Yaoundé","Cameroon","CM",{"type":51,"coordinates":52},"Point",[53,54],11.51667,3.86667,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":59,"phoneExt":23,"email":60},"Vincent Djientcheu, Doctor","(+237) 699 991 326","Vincent_djientcheu@yahoo.com",{"facility":62,"status":46,"city":47,"state":23,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Yaoundé University Teaching Hospital (CHU)",{"type":51,"coordinates":64},[53,54],{"lat":54,"lon":53},[67],{"name":68,"role":40,"phone":59,"phoneExt":23,"email":60},"Vincent Prof. Djientcheu, Prof.",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Prof. Patrick Petignat","Head of the Gynecologic Division",[74],{"name":75,"class":76},"Ecole Polytechnique Fédérale de Lausanne (EPFL), Campus Biotech","UNKNOWN","100635232","digital-telecytology-for-triage-of-hpv-positive-women-in-cameroon-100635232",false,"NCT07550010","Digital Telecytology for Triage of HPV-Positive Women in Cameroon","Evaluation of Digital Cytology for the Triage of HPV-positive Women in a Same-day \"Test-triage-treat\" Cervical Cancer Screening Strategy in Cameroon","Inclusion Criteria:\n\n* HIV-negative women aged 30-49 and HIV-positive women aged 25-49 years old\n* Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).\n\nExclusion Criteria:\n\n* Pregnancy at the time of screening\n* Previous hysterectomy\n* Known cervical cancer\n* Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)\n* Conditions that can interfere with visualization of the cervix\n* Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)\n* Women who are not able to comply with the study protocol.",true,"FEMALE","25 Years","50 Years",{"count":89,"type":90},1800,"ESTIMATED","INTERVENTIONAL",[93],"NA","This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings",[96,97,98],"Human Papillomavirus Infection","Cervical Intraepithelial Neoplasia Grade 2 (CIN2)","Cervical Cancer Screening Methods",[100,101,102,103,104],"HPV self-sampling","Telecytology","Artificial intelligence","Extended HPV genotyping","Low-resource settings","2026-04-17",{"date":107,"type":108},"2026-04-24","ACTUAL",{"date":110,"type":108},"2025-09-08",{"date":112,"type":90},"2027-09-08",{"name":5,"class":6},2]