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Studies

Interventional Recruiting

NCT06792604 on ClinicalTrials.gov

Host Genome Methylation: a Screening Tool in Anal Cancer Detection

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

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Enrollment: 770 (Estimated)
  • Study start: 2024-11-22 (Actual)
  • Primary completion: 2028-11-22 (Estimated)
  • Study completion: 2028-11-22 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: This study focuses on diagnostic and prognostic research for high-grade precancerous anal lesions. It is a prospective, single-centre, diagnostic and prognostic cohort study. Follow-up will vary depending on the HPV 16 result, but there is only one arm: cohort study.
  • Masking: None
  • PrimaryPurpose: Diagnostic

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).

Conditions

  • Anal Cancer

Intervention / Treatment

  • Device: Anal self-sampling (smear)
  • Behavioral: HPV questionnaire

Primary Outcome Measures

  • 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

Countries

France

Locations and Investigators

  • Pulmonology B and Lung Transplantation Department Bichat-Claude Bernard Hospital, Paris, France (Active not recruiting)
  • Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital, Paris, France (Active not recruiting)
  • Dermatology Department, Paris, France (Not yet recruiting)
  • Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital, Paris, France (Recruiting)
    • Clémentine GONTHIER, PhD
  • Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital, Paris, France (Active not recruiting)
  • Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital, Paris, France (Recruiting)
    • Jade GHOSN, PhD
  • Nephrology Department Bichat-Claude Bernard Hospital, Paris, France (Active not recruiting)
  • Pathological Anatomy and Cytology Department Bichat-Claude Hospital, Paris, France (Active not recruiting)
  • Virology Department Bichat-Claude Bernard Hospital, Paris, France (Active not recruiting)