NCT06792604 Host Genome Methylation: a Screening Tool in Anal Cancer Detection
| NCT ID | NCT06792604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Anal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 770 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2028-11-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 770 participants in total. It began in 2024-11-22 with a primary completion date of 2028-11-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06792604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06792604 currently recruiting?
Yes, NCT06792604 is actively recruiting participants. Contact the research team at valentinemarie.ferre@aphp.fr for enrollment information.
Where is the NCT06792604 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France, Paris, France and 5 additional locations.
Who is sponsoring the NCT06792604 clinical trial?
NCT06792604 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 770 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.