"Host Genome Methylation: a Screening Tool in Anal Cancer Detection"

What this Trial Is About

Researchers are evaluating the use of host genome methylation markers as a screening tool to detect anal cancer in at-risk populations. Anal cancer, though rare in the general population, affects certain groups more frequently, such as men who have sex with men (MSM) living with HIV, women with a history of vulvar lesions or cancer, and solid organ transplant recipients. In January 2023, the French National Society of Coloproctology issued the first national recommendations for anal cancer screening focusing on HPV16 detection followed by reflex cytology and proctological examination. This study aims to test the role of methylation markers ASCL1 and ZNF582 in triaging asymptomatic patients eligible for screening according to these guidelines. The study involves anal self-sampling (smear) at baseline and annually for HPV16-positive patients, with additional smears at 36 months for HPV16-negative patients. Participants will also complete an HPV questionnaire at various visits depending on their HPV16 status. The screening follows a stepwise approach starting with HPV16 testing, then cytology and proctological exams if positive, and referral for high-resolution anoscopy if abnormalities are found. This approach seeks to limit invasive procedures to patients with a higher risk of high-grade lesions by using methylation markers as predictive tools. Participants will be followed for three years with scheduled anal self-sampling and questionnaires to monitor progression to high-grade anal lesions, which is the primary outcome measured at 3 years. The study includes clinical assessments and molecular testing to evaluate methylation levels, aiming to improve screening and early detection of anal cancer in at-risk individuals. Safety and adherence to the study protocol will be monitored throughout the follow-up period.

Host Genome Methylation: a Screening Tool in Anal Cancer Detection