[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635232":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":51,"overallOfficials":32,"centralContacts":70,"locations":76,"responsibleParty":102,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":32,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":32,"studyType":124,"phases":125,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":79,"whyStopped":32,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+","Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios of HPV testing with digital cytology triage for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), using histology as the reference standard.","At baseline (initial screening visit)",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Feasibility of same-day test-triage-treat strategy","Proportion of HPV-positive women who receive cytology results on the same day among all HPV-positive women undergoing triage.","At baseline (same-day visit)",{"measure":19,"description":20,"timeFrame":21},"Diagnostic performance of AI-assisted telecytology for detection of CIN2+","Sensitivity, specificity, positive predictive value, and negative predictive value of AI-assisted telecytology for detection of cervical intraepithelial neoplasia grade 2 or worse, using histology as the reference standard.","At baseline",{"measure":23,"description":24,"timeFrame":21},"Detection rate of CIN2+ using AI-assisted VIA","Proportion of CIN2+ lesions detected by AI-assisted visual inspection with acetic acid (VIA) among HPV-positive women, using histology as reference.",{"measure":26,"description":27,"timeFrame":21},"Agreement between digital cytology and AI-assisted cytology","Agreement between standard digital cytology and AI-assisted cytology for the detection of cytological abnormalities (≥ ASC-US) among HPV-positive women.",{"measure":29,"description":30,"timeFrame":31},"Acceptability of HPV-based screening and triage strategy","Acceptability of HPV self-sampling, digital cytology, AI-assisted methods, and treatment procedures among participants and healthcare providers, assessed using structured questionnaires.","During study period (up to 26 months)",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","All participants will follow a single, predefined cervical cancer screening and management pathway. After HPV self-sampling, HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including same-day triage with digital telecytology, clinical assessment, and treatment or follow-up as indicated. No randomization or comparison between parallel study arms is performed.","SCREENING",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","This study is a prospective, single-center diagnostic accuracy and feasibility study conducted at the Yaoundé University Hospital in Cameroon. It evaluates a same-day cervical cancer screening strategy based on primary HPV testing with self-sampling, followed by triage using extended HPV genotyping and digital telecytology among HPV-positive women, within a test-triage-treat approach.\n\nWomen aged 30 to 49 years, and HIV-positive women aged 25 to 49 years, will be invited to participate following community-based awareness activities and hospital-based recruitment. After providing written informed consent, participants will perform HPV self-sampling. Primary screening will be conducted using the GeneXpert system, which provides rapid detection and genotyping of oncogenic HPV types.\n\nManagement of HPV-positive women will follow a predefined algorithm based on extended HPV genotyping. Women positive for HPV type 16 will be considered for immediate treatment following clinical assessment. Women positive for HPV types 18, 45, 31, 33, 35, 52, or 58 will undergo same-day triage using digital telecytology. Women positive for HPV types 51, 59, 39, 56, 66, or 68 will be scheduled for follow-up without immediate treatment unless clinically indicated.\n\nFor triage procedures, all HPV-positive women will undergo visual inspection with acetic acid (VIA), cervical cytology, and endocervical sampling, with either a VIA-directed biopsy or a random biopsy of the transformation zone, as appropriate. Cytology slides will be prepared locally and digitized for remote interpretation by trained cytopathologists. Women with cytological abnormalities of atypical squamous cells of undetermined significance (ASC-US) or worse will be offered same-day treatment with thermal ablation. Histological assessment of endocervical samples and biopsies will serve as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).\n\nArtificial intelligence-assisted telecytology and AI-assisted VIA will be evaluated as secondary diagnostic tools. These AI-based analyses will not be used for clinical decision-making but will be assessed retrospectively to determine their diagnostic performance and concordance with standard interpretation.\n\nEligible women diagnosed with CIN2+ will be offered treatment, if not already performed, primarily with thermal ablation, in accordance with World Health Organization eligibility criteria and local standards of care. Women with suspected invasive cancer will be referred for further diagnostic evaluation and appropriate management.\n\nParticipants who receive treatment will be followed by telephone at 4 to 6 weeks to assess adverse events and acceptability. All HPV-positive women will be invited for a follow-up visit at 12 months, including repeat HPV testing and additional examinations as clinically indicated. Acceptability of screening and treatment strategies will be assessed among participants and healthcare providers using standardized questionnaires.\n\nThe study aims to assess the diagnostic accuracy, feasibility, and acceptability of a scalable, same-day HPV-based cervical cancer screening strategy incorporating digital telecytology and artificial intelligence in a low-resource setting.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"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.",[47,48,49,50],"Diagnostic Test: HPV testing (self-sampling)","Diagnostic Test: Digital telecytology","Diagnostic Test: AI-assisted telecytology","Procedure: Thermal ablation",[52,57,61,65],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"DIAGNOSTIC_TEST","HPV testing (self-sampling)","HPV testing performed on self-collected vaginal samples providing extended genotyping for high-risk HPV types.",[43],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":32},"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).",[43],{"type":53,"name":62,"description":63,"armGroupLabels":64,"otherNames":32},"AI-assisted telecytology","Artificial intelligence-assisted analysis of digital cytology images to support detection of cervical abnormalities in HPV-positive women.",[43],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":32},"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).",[43],[71],{"name":72,"role":73,"phone":74,"phoneExt":32,"email":75},"Patrick Petignat, Doctor; Professor","CONTACT","+41 22 37 24 432","patrick.petignat@hug.ch",[77,94],{"facility":78,"status":79,"city":80,"state":32,"zip":32,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Centre Hospitalier Universitaire de Yaoundé","RECRUITING","Yaoundé","Cameroon","CM",{"type":84,"coordinates":85},"Point",[86,87],11.51667,3.86667,{"lat":87,"lon":86},[90],{"name":91,"role":73,"phone":92,"phoneExt":32,"email":93},"Vincent Djientcheu, Doctor","(+237) 699 991 326","Vincent_djientcheu@yahoo.com",{"facility":95,"status":79,"city":80,"state":32,"zip":32,"country":81,"countryCode":82,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Yaoundé University Teaching Hospital (CHU)",{"type":84,"coordinates":97},[86,87],{"lat":87,"lon":86},[100],{"name":101,"role":73,"phone":92,"phoneExt":32,"email":93},"Vincent Prof. Djientcheu, Prof.",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Prof. Patrick Petignat","Head of the Gynecologic Division",[107],{"name":108,"class":109},"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":122,"type":123},1800,"ESTIMATED","INTERVENTIONAL",[34],"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",[128,129,130],"Human Papillomavirus Infection","Cervical Intraepithelial Neoplasia Grade 2 (CIN2)","Cervical Cancer Screening Methods",[132,133,134,135,136],"HPV self-sampling","Telecytology","Artificial intelligence","Extended HPV genotyping","Low-resource settings","2026-04-17",{"date":139,"type":140},"2026-04-24","ACTUAL",{"date":142,"type":140},"2025-09-08",{"date":144,"type":123},"2027-09-08",{"name":5,"class":6},2]