Host Genome Methylation: a Screening Tool in Anal Cancer Detection

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (age ≥ 18 years)

• 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

Locations
Other Locations
France
Cardiovascular Surgery and Transplantation Department Bichat-Claude Bernard Hospital
ACTIVE_NOT_RECRUITING
Paris
Dermatology Department
NOT_YET_RECRUITING
Paris
Gynecology and Obstetrics Department Bichat-Claude Bernard Hospital
RECRUITING
Paris
Hepato-Gastroenterology, Digestive Oncology, and Proctology Department Bichat-Claude Bernard Hospital
ACTIVE_NOT_RECRUITING
Paris
Infectious and Tropical Diseases Department Bichat-Claude Bernard Hospital
RECRUITING
Paris
Nephrology Department Bichat-Claude Bernard Hospital
ACTIVE_NOT_RECRUITING
Paris
Pathological Anatomy and Cytology Department Bichat-Claude Hospital
ACTIVE_NOT_RECRUITING
Paris
Pulmonology B and Lung Transplantation Department Bichat-Claude Bernard Hospital
ACTIVE_NOT_RECRUITING
Paris
Virology Department Bichat-Claude Bernard Hospital
ACTIVE_NOT_RECRUITING
Paris
Contact Information
Primary
Valentine FERRE, PhD
valentinemarie.ferre@aphp.fr
01.40.25.88.96
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2028-11-22
Participants
Target number of participants: 770
Treatments
Other: Cohort
Patient HPV16 + at inclusion :~* Cytological analysis of the smear~* Referral to proctology (recommendation): Standard proctological examination Additional self-samples will be taken at 1 year (M12), 2 years (M24) and 3 years (M36 - end of follow-up) during a visit as part of standard care Questionnaire carried out at 1 year (M12), 2 years (M24) and 3 years (M36 - end of follow-up) during a visit as part of standard care~And if cytology positive or if anal symptoms :~* Standard proctological examination~* Anal smear at clinician's discretion (virological analysis)~* Anal biopsy if necessary (cytological analysis)~* AHR (high-resolution anoscopy)~Patient HPV16 - at inclusion :~* Additional self-sampling at 3 years during a visit as part of standard care~* Questionnaire carried out at 3 years during a visit as part of standard care And if anal symptom~* Standard proctological examination, Anal smear, AHR at clinician's discretion~* Anal biopsy if necessary
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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