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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-resolution anoscopy.
- Who it may be relevant to
- Registry conditions: HPV Infection, Anal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure High-resolution anoscopy
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 outcome measures
- 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 outcome measures (5)
- 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.]
- Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions. [Time frame: 10 years after participation in the ANRS IPERGAY trial]
- 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.]
- Nature of abnormalities on anal histology of lesions: location, type, grade [Time frame: 10 years after participation in the ANRS IPERGAY trial]
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 3 centers
- Hôpital de la Croix Rousse - SMIT — Lyon
- Hôpital Saint-Louis - SMIT — Paris
- Hôpital Tenon - SMIT — Paris
Identifiers
NCT: NCT06522256 · ANRS0251s-HPVSign