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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
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
Hôpital de la Croix Rousse - SMIT
Lyon, France
RECRUITINGHôpital Saint-Louis - SMIT
Paris, France
RECRUITINGHôpital Tenon - SMIT
Paris, France
RECRUITINGHigh-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.
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.
Lesions and condylomas are described as follows: location and type.
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.
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