Clinical trial · Interventional
Host Genome Methylation: a Screening Tool in Anal Cancer Detection
"Host Genome Methylation: a Screening Tool in Anal Cancer Detection"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anal self-sampling (smear) | Device | — | UNRESOLVED |
| HPV questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cohort
- description
- 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
- interventionNames
- Device: Anal self-sampling (smear)
- Behavioral: HPV questionnaire
Primary outcomes (1)
- measure
- High- grade anal lesion at 3 years
- timeFrame
- 3 years after Inclusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults (age ≥ 18 years) 2. 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 Non-inclusion Criteria: 1. Proctological follow-up for a current high-grade anal lesion or cancer 2. Pregnant or breastfeeding women 3. Subject deprived of liberty or under legal protection 4. Non-affiliation with social security system 5. Refusal to participate expressed by the patient Exclusion Criteria : 1\) Refusal of anal self-sampling on inclusion
References
Publications (0)
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