Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06792604

Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-24

770

Participants Needed

9

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Eligible for anal cancer screening based on SNFCP guidelines, including:
    • Men who have sex with men aged over 30 living with HIV
    • Patients who received a solid organ transplant more than 10 years ago
    • Women with a history of vulvar lesions or vulvar cancer
Not Eligible

You will not qualify if you...

  • Current proctological follow-up for high-grade anal lesion or anal cancer
  • Pregnant or breastfeeding women
  • Persons deprived of liberty or under legal protection
  • Not affiliated with the social security system
  • Refusal to participate in the study
  • Refusal to perform anal self-sampling at inclusion

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Active, Not Recruiting

2

Dermatology Department

Paris, Île-de-France Region, France, 75018

Not Yet Recruiting

3

Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Actively Recruiting

4

Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Active, Not Recruiting

5

Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Actively Recruiting

6

Nephrology Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Active, Not Recruiting

7

Pathological Anatomy and Cytology Department Bichat-Claude Hospital

Paris, Île-de-France Region, France, 75018

Active, Not Recruiting

8

Pulmonology B and Lung Transplantation Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Active, Not Recruiting

9

Virology Department Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, France, 75018

Active, Not Recruiting

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Research Team

V

Valentine FERRE, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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