Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HPV Infection
Anal Cancer
Keywords: HSIL
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: INSERM SC10-US19
First posted: 2024-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Transversal, non-comparative, multicenter study.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)
timeFrame: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.
Secondary outcomes:
measure: HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome
timeFrame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
measure: Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.
timeFrame: 10 years after participation in the ANRS IPERGAY trial
measure: Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.
timeFrame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
measure: Nature of abnormalities on anal histology of lesions: location, type, grade
timeFrame: 10 years after participation in the ANRS IPERGAY trial
measure: Presence of different HPV virus types in the oropharynx
timeFrame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - SMIT
city: Paris
country: France
facility: Hôpital Saint-Louis - SMIT
city: Paris
country: France
facility: Hôpital Tenon - SMIT
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Caroline Lascoux-Combe, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen Georges-Pompidou
name: David Veyer, Pharm D,PhD
role: STUDY_DIRECTOR
References: