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Screening tool for anal cancer detection using host genome methylation

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

NA · Assistance Publique - Hôpitaux de Paris · NCT06792604

This study is trying to create a new screening tool for anal cancer that uses genetic markers to help high-risk groups, like men with HIV and women with past cancer, get tested more easily.

Quick facts

PhaseNA
Study typeInterventional
Enrollment770 (estimated)
Ages18 Years and up
SexAll
SponsorAssistance Publique - Hôpitaux de Paris (other)
Locations9 sites (Paris, Île-de-France Region and 8 other locations)
Trial IDNCT06792604 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study include MSM aged over 30 living with HIV, patients who have received solid organ transplants for more than 10 years, and women with a history of vulvar lesions or vulvar cancer.

Not a fit: Patients currently undergoing proctological follow-up for high-grade anal lesions or cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of anal cancer in high-risk populations, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown success in using biological markers for cancer screening, but this specific approach is novel and untested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Paris, Île-de-France Region and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Anal Cancer, HIV, MSM, Solid organ transplant, Vulvar lesions, Vulvar cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.