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Search / Trial NCT06792604

Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 21, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hiv Msm Solid Organ Transplant Vulvar Lesions Vulvar Cancer

ClinConnect Summary

This clinical trial is looking at new ways to help detect anal cancer in certain at-risk groups using specific biological markers found in anal samples. The study is based on recent guidelines that recommend screening for anal cancer for people who are more likely to develop the disease, especially those living with HIV, women with a history of vulvar issues, and men who have had solid organ transplants for over ten years. The trial will test whether measuring the levels of markers called ZNF582 and ASCL1 in anal smears can help identify individuals who may need further examination for anal cancer.

To participate, you must be an adult aged 18 or older who meets the screening criteria set by the French National Society of Coloproctology. You should be either a man who has sex with men and is over 30 years old and living with HIV, a woman with a history of vulvar lesions or cancer, or a man or woman who has had a solid organ transplant for more than ten years. If you join, you'll provide an anal sample, and the study will track whether the markers can accurately indicate your risk for developing anal cancer. This research aims to improve the way we screen for anal cancer and ensure that those who need additional tests can receive them more effectively.

Gender

ALL

Eligibility 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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, Ile De France, France

Paris, île De France, France

Paris, île De France, France

Paris, île De France, France

Paris, île De France, France

Paris, île De France, France

Paris, île De France, France

Paris, île De France, France

Paris, île De France, France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported