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

Not Applicable

Not yet recruiting

• Conditions: Anal Cancer; HPV Infection
• Interventions: Procedure: High-resolution anoscopy

• Registration Number: NCT06522256
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-26
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Start: 2024-09-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-resolution anoscopy	High-resolution anoscopy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 anal histology of lesions: location, type, grade	10 years after participation in the ANRS IPERGAY trial
Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.	10 years after participation in the ANRS IPERGAY trial	Lesions and condylomas are described as follows: location and type.
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.
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.

Trial Locations

Locations (3)

Hôpital de la Croix Rousse - SMIT; 🇫🇷 Lyon, France

Hôpital Saint-Louis - SMIT; 🇫🇷 Paris, France

Hôpital Tenon - SMIT; 🇫🇷 Paris, France