Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Condition(s) studied

Investigational drug(s) / intervention(s)

Anal self-sampling (smear): 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: 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 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

Primary outcome measure(s)

• High- grade anal lesion at 3 years — 3 years after Inclusion
  Analyse if methylation markers on an initial anal self sample (M0) could predict high grade anal lesion at M3

Trial sites (9)

More Assistance Publique - Hôpitaux de Paris trials in France

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