[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556688":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":24,"responsibleParty":36,"collaborators":24,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":24,"enrollmentInfo":49,"targetDuration":24,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":24},{"fullName":5,"class":6},"UNICANCER","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control group","For the first 500 participants enrolled, one additional blood sample will be drawn in DNA-free tubes for HPV ctDNA analysis. As we expect to have around 1% seropositive cases, most of these 500 samples will be seronegative and will constitute our control group. These controls will be tested for HPV ctDNA to confirm that seronegative participants are also HPV ctDNA-negative",[12],"Diagnostic Test: HPV16-E6 serology and HPV ctDNA",{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental Group","EXPERIMENTAL","Individuals who are seropositive for HPV16-E6 will be contacted to propose the participation in the second part of the study and benefit from specific assessment and monitoring for 5 years (HPV ctDNA testing, regular clinical examinations of the head \\& neck and anal-genital regions, imaging if needed).",[12],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","HPV16-E6 serology and HPV ctDNA","In the event of a malignant lesion identified on clinical examination and\u002For imaging, treatment will be performed according to the standard of care. In the absence of any suspicious lesion, but in the event of HPV ctDNA positivity, prophylactic surgery of the tonsils and base of the tongue (the vast majority of HPV-related OPC develop in these regions) will be proposed to the patient, given the high risk of OPC. In case of refusal of this prophylactic surgery, close clinical and imaging monitoring will be performed.\n\nSurgical specimens will be analyzed to confirm or not the presence of HPV-driven OPC and HPV ctDNA will be measured post-operatively to ensure disease clearance.",[9,14],null,[26],{"name":27,"affiliation":28,"role":29},"Haïtham Mirghani","APHP","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Michaël CHEVROT","CONTACT","0171936161","m-chevrot@unicancer.fr",{"type":37,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100556688","blood-biomarkers-based-screening-for-hpv-driven-opc-100556688",false,"NCT06528353","Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV","Inclusion Criteria:\n\n* Aged ≥50 years from the general population\n* Man\n* No previous history of HPV-driven cancer or head neck cancer\n* Willingness to complete follow up visits\n\nExclusion Criteria:\n\n* Aged \\\u003C 50 years\n* Woman\n* History of HPV-driven cancer or head and neck cancer\n* Psychiatric conditions\n* Inability to complete follow up visits\n* Severe medical condition (life expectancy \\\u003C5 years)\n* Previous prophylactic HPV vaccination",true,"MALE","50 Years",{"count":50,"type":51},10000,"ESTIMATED","INTERVENTIONAL",[54],"NA","The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and\u002For whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.",[57,58,59],"Head and Neck Squamous Cell Carcinoma","Anal Cancer","Human Papilloma Virus",[61,62,63,64,65],"HPV-induced cancer","Head and Neck Cancers","virology","serology","secondary cancer prevention","NOT_YET_RECRUITING","2026-05-22",{"date":69,"type":70},"2026-05-26","ACTUAL",{"date":72,"type":51},"2026-09",{"date":74,"type":51},"2032-09",{"name":5,"class":6}]