Anal cancer screening for men on PrEP
Screening for Anal Cancer in MSM Using PrEP
This study will test how well anal swabs and DNA methylation testing find high-grade anal lesions (HSIL) and how common those lesions are in men who have sex with men using PrEP, and whether HSIL affects quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 35 Years and up |
| Sex | Male |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 8 sites (Bruges and 7 other locations) |
| Trial ID | NCT07029152 on ClinicalTrials.gov |
What this trial studies
This multicenter study enrolls HIV-uninfected men who have sex with men aged 35 or older who have used PrEP for at least three months. Participants complete health and quality-of-life questionnaires, provide an anal smear, and undergo high-resolution anoscopy (HRA) with biopsy when indicated. Anal cytology results will be compared to HRA/biopsy findings to measure screening accuracy, and DNA methylation testing will be run on samples to explore molecular markers for HSIL. The study will estimate HSIL prevalence in this PrEP-using population and describe any associated quality-of-life impacts.
Who should consider this trial
Good fit: Ideal candidates are HIV-uninfected men who have sex with men aged 35 or older who have been taking PrEP for at least three months and can speak Dutch, English, or French.
Not a fit: People who are HIV-positive, younger than 35, not using PrEP, or unable/unwilling to attend in-person HRA visits are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the study could improve early detection of precancerous anal lesions in PrEP-using men and help tailor screening strategies to reduce future anal cancer risk.
How similar studies have performed: Anal cytology and HRA are established screening approaches for detecting HSIL, while DNA methylation testing is a newer, promising technique with encouraging results in related HPV-driven lesions but is still emerging for anal disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV-uninfected MSM (men who have sex with men) aged 35 years or older. * participants must have been using PrEP for at least 3 months. * Dutch, English or French speaking and writing Exclusion Criteria: * Any intervention in the (peri-)anal region within the past 3 months * Enema usage within 2 h before sampling * Currently undergoing peri-anal topical HPV-treatment * HRA in the last year (anal swab or HRA prior to the last year is no exclusion)
Where this trial is running
Bruges and 7 other locations
- AZ Sint Jan — Bruges, Belgium (Active_not_recruiting)
- CHU Saint-Pierre — Brussels, Belgium (Recruiting)
- Cliniques universitaires Saint-Luc - UCLouvain — Brussels, Belgium (Recruiting)
- UZ Brussel — Brussels, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Recruiting)
- Jessaziekenhuis — Hasselt, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Active_not_recruiting)
- CHU Charleroi - Chimay — Lodelinsart, Belgium (Recruiting)
Study contacts
- Study coordinator: Magali Surmont
- Email: magali.surmont@uzbrussel.be
- Phone: 024776001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.