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

NCT06522256 | Recruiting DMC

• 1 other identifier: ANRS0251s-HPVSign
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HPV Infection; Anal Cancer

Keywords

HSIL

Outcome Measures

Primary Outcomes (1)

• High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)

  Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.

Secondary Outcomes (5)

• HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome

  at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

• Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.

  10 years after participation in the ANRS IPERGAY trial

• Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.

  at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

• Nature of abnormalities on anal histology of lesions: location, type, grade

  10 years after participation in the ANRS IPERGAY trial

• Presence of different HPV virus types in the oropharynx

  at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

Study Arms (1)

High-resolution anoscopy

OTHER

Procedure: High-resolution anoscopy

Interventions

High-resolution anoscopy PROCEDURE

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

High-resolution anoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• INSERM SC10-US19: collaborator

Study Sites (3)

Hôpital de la Croix Rousse - SMIT

Lyon, 69004, France

RECRUITING

Hôpital Saint-Louis - SMIT

Paris, 75010, France

RECRUITING

Hôpital Tenon - SMIT

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections; Anus Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Caroline Lascoux-Combe, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• David Veyer, Pharm D,PhD

  Hôpital Européen Georges-Pompidou

  STUDY DIRECTOR

Central Study Contacts

Fatoumata Coulibaly

CONTACT

0144236110; fatoumata.coulibay@inserm.fr

Mathilde Ghislain, MSc

CONTACT

0145595229; mathilde.ghislain@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Transversal, non-comparative, multicenter study.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-02

Locations

FR (3)