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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2027-07-30

Brief Summary

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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.

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Detailed Description

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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

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HPV Infection Anal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Transversal, non-comparative, multicenter study.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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High-resolution anoscopy

Group Type OTHER

High-resolution anoscopy

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes