Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Recruiting now · Not applicable

Conditions studied: Anal Cancer

In brief

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 facts

Study ID

NCT06792604

Run by

Assistance Publique - Hôpitaux de Paris

People needed

770

Starts

2024-11-22

Expected to finish

2028-11-22

Last updated by the study team

2025-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Non-inclusion Criteria:
• 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

You may not qualify if…

• Refusal of anal self-sampling on inclusion

Where it is running

• Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France (enrolling)
• Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France (enrolling)
• Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France
• Nephrology Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France
• Pathological Anatomy and Cytology Department Bichat-Claude Hospital — Paris, Île-de-France Region, France
• Pulmonology B and Lung Transplantation Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France
• Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France
• Virology Department Bichat-Claude Bernard Hospital — Paris, Île-de-France Region, France
• Dermatology Department — Paris, Île-de-France Region, France

Full record on ClinicalTrials.gov

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