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NCT Number: 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

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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Key information

Conditions

HPV Infection Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse - SMIT, Lyon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-resolution anoscopy

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

Primary outcomes

  1. High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)

    Time frame: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.

Secondary outcomes

  1. HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome

    Time frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

  2. Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.

    Time frame: 10 years after participation in the ANRS IPERGAY trial

    Lesions and condylomas are described as follows: location and type.

  3. Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.

    Time frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

  4. Nature of abnormalities on anal histology of lesions: location, type, grade

    Time frame: 10 years after participation in the ANRS IPERGAY trial

  5. Presence of different HPV virus types in the oropharynx

    Time frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatoumata Coulibaly

CONTACT

[email protected]

0144236110 ext. +33

Mathilde Ghislain, MSc

CONTACT

[email protected]

0145595229 ext. +33

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • INSERM SC10-US19

Registry information

Acronym: HPVsign

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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