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 (HPVsign)

November 27, 2025 updated by: ANRS, Emerging Infectious Diseases
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Hôpital de la Croix Rousse - SMIT
        • Contact:
        • Principal Investigator:
          • Dulce Alfaiate, Dr
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis - SMIT
        • Contact:
        • Principal Investigator:
          • Caroline Lascoux-Combe, Dr
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon - SMIT
        • Principal Investigator:
          • Gilles Pialoux, Pr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: High-resolution anoscopy
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome
Time Frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
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.
Time Frame: 10 years after participation in the ANRS IPERGAY trial
Lesions and condylomas are described as follows: location and type.
10 years after participation in the ANRS IPERGAY trial
Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.
Time Frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
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
Time Frame: 10 years after participation in the ANRS IPERGAY trial
10 years after participation in the ANRS IPERGAY trial
Presence of different HPV virus types in the oropharynx
Time Frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

INSERM SC10-US19

Investigators

  • Principal Investigator: Caroline Lascoux-Combe, Dr, Assistance Publique - Hôpitaux de Paris
  • Study Director: David Veyer, Pharm D,PhD, Hôpital Européen Georges-Pompidou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS0251s-HPVSign

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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