Study ANRS0251s-HPVSign

Molecular signatures of high-risk oncogenic HPVs

Last updated on 06 September 2024

In brief

Identification of molecular signatures of high-risk oncogenic Human PapillomaVirus (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.

The HPVsign study is a cross-sectional, non-comparative, multicentre study involving all participants included in the HPV sub-study of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high grade lesions (HSIL) 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.

Objectives

Primary:

  • Assess the cumulative incidence of high-grade lesions and/or anal cancers objectified by the gold standard diagnostic test for these lesions, high-resolution anoscopy (HRA), during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.

Secondary:

  • Study the association between the presence of high-grade lesions and/or anal cancer and the available HPV molecular signatures generated by Capture-HPV (capture + high-throughput sequencing) on sequential anal swabs obtained during participation in the ANRS IPERGAY trial.
  • Study the association between the presence of high-grade lesions and/or anal cancer and the available HPV molecular signatures generated by Capture-HPV (capture + high-throughput sequencing) on sequential anal swabs obtained 10 years after inclusion in the ANRS IPERGAY trial (contemporaneous with AHR).
  • Study the evolution of HPV molecular signatures between initial samples (obtained during participation in the ANRS IPERGAY trial) and samples taken 10 years later (persistence, evolution, integration).
  • Compare the results of AHR with the results of anal cytology concomitant with AHR.
  • Compare the results of anal cytology concomitant with AHR with those obtained during participation in the ANRS IPERGAY trial.
  • Study the factors associated with the presence of high-grade lesions and/or anal cancer.
  • Compare the presence of different types of HPV virus in the oropharynx concomitant with HRT and during participation in the ANRS IPERGAY trial.

Coordinating investigator / Scientific manager
Dr Caroline Lascoux-Combe / Dr David Veyer

Pathology
Human papillomavirus, Anal cancer

Structure/teams
Equipe FunGeST UMRS1138, INSERM SC10 / US019, SMIT Hôpital Saint-Louis, Hôpital Cochin – Anapath

Study start/end dates
4th quarter 2024/ 4th quarter 2027

Sponsorship and funding
Inserm-ANRS MIE

Number of participants
80-100

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