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Host Genome Methylation: a Screening Tool in Anal Cancer Detection

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06792604 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 de

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📋 Eligibility rules (as published)
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
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What it tests

  • Anal self-sampling (smear)
  • HPV questionnaire
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Where

9 sites
Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital
Paris, France
Dermatology Department
Paris, France
Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital
Paris, France
Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital
Paris, France
Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital
Paris, France
Nephrology Department Bichat-Claude Bernard Hospital
Paris, France
Pathological Anatomy and Cytology Department Bichat-Claude Hospital
Paris, France
Pulmonology B and Lung Transplantation Department Bichat-Claude Bernard Hospital
Paris, France

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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