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)

ANRS, Emerging Infectious Diseases

Status: Not yet enrolling

Conditions: Anal Cancer; HPV Infection

Treatments: Procedure: High-resolution anoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06522256

ANRS0251s-HPVSign

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

High-resolution anoscopy

Other group

Treatment:

Procedure: High-resolution anoscopy