HPV molecular patterns linked to high-grade anal lesions and cancer in former IPERGAY participants
Official title: 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
Run by ANRS, Emerging Infectious Diseases · NCT06522256 · Data updated 2026-11-12
This project will test whether specific HPV molecular signatures predict high-grade anal lesions or anal cancer in people who were part of the IPERGAY HPV substudy about 10 years earlier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 3 sites (Lyon and 2 other locations) |
| Status | Recruiting |
| Started | March 20, 2025 |
| Main results expected | July 30, 2027 |
| Study ends | July 30, 2027 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT06522256 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People who participated in the ANRS IPERGAY trial's HPV substudy, can give written informed consent, and have regular French health insurance are eligible to join.
✕Probably not a fit
People who did not take part in the original IPERGAY HPV substudy, those without HPV infection, or those unable to travel to the French study sites are unlikely to gain direct benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
HPVsign is a cross-sectional, multicenter follow-up of 80–100 participants from the ANRS IPERGAY HPV substudy who will undergo high-resolution anoscopy (HRA) and sampling. The study compares current HRA and anal cytology findings with samples and molecular HPV data collected during IPERGAY to see how HPV signatures evolved. Investigators will link current presence of HSIL and/or anal cancer to prior and current HPV molecular profiles and will also compare anal and oropharyngeal HPV types. The protocol includes analysis of factors associated with HSIL/anal cancer and concordance between HRA and cytology results.
Why it matters
Potential benefit: If successful, the findings could help identify people at higher long-term risk so they can receive targeted monitoring or earlier treatment.
How similar studies have gone: Previous research has linked high-risk HPV types to anal HSIL and cancer, but following detailed HPV molecular signatures over a decade within a single cohort is largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study; * Informed and written signed consent * Participant with regular health insurance Exclusion Criteria: * Participant under guardianship or curatorship * Participant with free State medical assistance * Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.
Where it's running
-
Hôpital de la Croix Rousse - SMIT
Lyon, France Recruiting -
Hôpital Saint-Louis - SMIT
Paris, France Recruiting -
Hôpital Tenon - SMIT
Paris, France Recruiting
Study contacts
- Principal investigator: Caroline Lascoux-Combe, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Fatoumata Coulibaly
- Email: fatoumata.coulibay@inserm.fr
- Phone: 0144236110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.