Brief Summary

In January 2023, the first recommendations for anal cancer screening were issued by the French National Society of Coloproctology (SNFCP). These were the world's first national recommendations for anal cancer screening for at-risk patients, not limited to people living with HIV. They are based on screening for papillomavirus type 16 (HPV16) as the first line of defence, followed by reflex cytology in the event of a positive HPV16 smear and a proctological examination. In the event of abnormal cytology or proctological examination, high-resolution anoscopy (HRA) should be performed, but access to it is limited by the number of proctologists with the expertise to carry out this examination and the cost of the equipment. The development of biological markers could enable only patients at high risk of high-grade dysplasia/anal cancer to be referred for HRA. As part of the AIN3 cohort, we demonstrated that the markers ZNF582 and ASCL1, studied on anal smears taken when patients were included in the cohort, showed a significantly higher level of methylation in patients who subsequently progressed to anal cancer. The aim of this project is to test, in real-life conditions, the contribution of these methylation markers in the triage of asymptomatic patients eligible for anal cancer screening according to the SNFCP guidelines (MSM over 30 years of age living with HIV, women with a history of vulvar lesions or vulvar, women patients who have had a solid organ transplant for more than 10 years and extension to men patients who have had a solid organ transplant for more than 10 years).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

770

participants targeted

Target at P75+ for not_applicable

Timeline

30mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Progress39%

Nov 2024Nov 2028

Study Start

First participant enrolled

November 22, 2024

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed

14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2028

Last Updated

January 24, 2025

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

January 10, 2025

Last Update Submit

January 21, 2025

Conditions

Anal Cancer

Keywords

HIVMSMSolid organ transplantVulvar lesionsVulvar cancer

Outcome Measures

Primary Outcomes (1)

High- grade anal lesion at 3 years
Analyse if methylation markers on an initial anal self sample (M0) could predict high grade anal lesion at M3
3 years after Inclusion

Secondary Outcomes (9)

HSIL cytology on the anal self-sample at 3 year in HPV 16 negative patients at M0
3 years after Inclusion
High grade anal lesion in HPV 16 positive patients at M0
1 year, 2 years, 3 years after inclusion
Diagnostic properties of methylation in HPV 16-positive patients at M0
M0
Persistance of HPV infection
4 years after the inclusion of the first patient
Time for HPV16 clearance
3 years after Inclusion
+4 more secondary outcomes

Study Arms (1)

Cohort

OTHER

Patient HPV16 + at inclusion : * Cytological analysis of the smear * Referral to proctology (recommendation): Standard proctological examination Additional self-samples will be taken at 1 year (M12), 2 years (M24) and 3 years (M36 - end of follow-up) during a visit as part of standard care Questionnaire carried out at 1 year (M12), 2 years (M24) and 3 years (M36 - end of follow-up) during a visit as part of standard care And if cytology positive or if anal symptoms : * Standard proctological examination * Anal smear at clinician's discretion (virological analysis) * Anal biopsy if necessary (cytological analysis) * AHR (high-resolution anoscopy) Patient HPV16 - at inclusion : * Additional self-sampling at 3 years during a visit as part of standard care * Questionnaire carried out at 3 years during a visit as part of standard care And if anal symptom * Standard proctological examination, Anal smear, AHR at clinician's discretion * Anal biopsy if necessary

Device: Anal self-sampling (smear)Behavioral: HPV questionnaire

Interventions

Anal self-sampling (smear)DEVICE

Anal self-sampling (smear) at M12, M24 and M36 (each year) for HPV16+ patients at M0 and anal self-sampling (smear) at M36 for HPV16- at M0

Cohort

HPV questionnaireBEHAVIORAL

HPV questionnaire at each visit M0, M12, M24 and M36 for HPV16-positive patients at M0 and HPV questionnaire at each visit M0, 4 and M36 for HPV16-negative patients

Cohort

Eligibility Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Gender Eligibility DetailsMSM (men who have sex with men) over 30 years old living with HIV Women with a history of vulvar lesions or vulvar cancer

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults (age ≥ 18 years)
Eligible for anal cancer screening according to the SNFCP guidelines (with extension to men who have received solid organ transplants for more than 10 years):
MSM (men who have sex with men) aged over 30 living with HIV
Patients who have received a solid organ transplant for more than 10 years
Women with a history of vulvar lesions or vulvar cancer
Proctological follow-up for a current high-grade anal lesion or cancer
Pregnant or breastfeeding women
Subject deprived of liberty or under legal protection
Non-affiliation with social security system
Refusal to participate expressed by the patient

Contact the study team to confirm eligibility.