Anal Cancer, HPV Infection
Conditions
Keywords
HSIL
Brief summary
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
PROCEDUREHigh-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
Sponsors
INSERM SC10-US19
ANRS, Emerging Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Transversal, non-comparative, multicenter study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA) | Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome | 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. | 10 years after participation in the ANRS IPERGAY trial | Lesions and condylomas are described as follows: location and type. |
| Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade. | 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 | 10 years after participation in the ANRS IPERGAY trial | — |
| Presence of different HPV virus types in the oropharynx | at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study. | — |
Countries
France
Contacts
Primary ContactFatoumata Coulibaly
Backup ContactMathilde Ghislain, MSc
Outcome results
None listed