Screening tool for anal cancer detection using host genome methylation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to develop a screening tool for anal cancer detection by utilizing host genome methylation markers. It focuses on high-risk populations, including men who have sex with men (MSM) living with HIV, patients with a history of solid organ transplants, and women with previous vulvar lesions or cancer. The study will involve anal self-sampling and HPV questionnaires to identify individuals who may require further examination, such as high-resolution anoscopy (HRA). The goal is to improve access to screening and reduce the burden on healthcare resources while ensuring that only those at high risk are referred for invasive procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (age ≥ 18 years)
2. 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:

1. Proctological follow-up for a current high-grade anal lesion or cancer
2. Pregnant or breastfeeding women
3. Subject deprived of liberty or under legal protection
4. Non-affiliation with social security system
5. Refusal to participate expressed by the patient

Exclusion Criteria :

1\) Refusal of anal self-sampling on inclusion

Where it's running

• Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital
  Paris, Île-de-France Region, France Recruiting
• Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital
  Paris, Île-de-France Region, France Recruiting
• Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital
  Paris, Île-de-France Region, France Active not recruiting
• Dermatology Department
  Paris, Île-de-France Region, France Not yet recruiting
• Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital
  Paris, Île-de-France Region, France Active not recruiting
• Nephrology Department Bichat-Claude Bernard Hospital
  Paris, Île-de-France Region, France Active not recruiting

Study contacts

• Study coordinator: Valentine FERRE, PhD
• Email: valentinemarie.ferre@aphp.fr
• Phone: 01.40.25.88.96

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.