Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06792604
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • HPV questionnaire — BEHAVIORAL
    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

Study Details

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).

Key Dates

Start date
Nov 22, 2024
Status verified
Dec 2024
Primary completion
Nov 22, 2028
Completion
Nov 22, 2028

Study Design

Enrollment
770 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Cohort
    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

Primary Outcome Measure

High- grade anal lesion at 3 years [ Time Frame: 3 years after Inclusion ]

Central Contacts

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