NCT06522256

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy. 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. Also, the study proposes to: * study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after. * study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study * compare HRA results with anal cytology results * compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial. * study factors associated with the presence of HSIL and/or anal cancer. * compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.

Conditions

• HPV Infection
• Anal Cancer

Interventions

Type	Name	Description
PROCEDURE	High-resolution anoscopy	The study includes 2 visits: * a medical consultation for inclusion * a proctology consultation including the performance of an AHR associated or not with biopsy sampling

Timeline

• Start date: 2025-03-20
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2024-07-26
• Last updated: 2025-12-04

Locations

3 sites across 1 country: France