Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
- Sponsor
- ANRS, Emerging Infectious Diseases
- Study ID
- NCT06522256
- Status
- Recruiting
Conditions
- Anal Cancer
- HPV Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- High-resolution anoscopy — PROCEDUREThe study includes 2 visits: * a medical consultation for inclusion * a proctology consultation including the performance of an AHR associated or not with biopsy sampling
Study Details
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Key Dates
- Start date
- Mar 20, 2025
- Status verified
- Feb 2025
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Other: High-resolution anoscopy
Primary Outcome Measure
High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA) [ Time Frame: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study. ]
Central Contacts
- Fatoumata Coulibaly0144236110
- Mathilde Ghislain, MSc0145595229
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