Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis

Recruiting now · Not applicable

Conditions studied: Anal Cancer, Squamous Intraepithelial Lesions, HSIL, High Grade Squamous Intraepithelial Lesions, LSIL, Low-Grade Squamous Intraepithelial Lesions, HPV, Squamous Cell Carcinoma

In brief

This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Specifically, we want to check how common High-Grade Squamous Intraepithelial Lesions (HSIL) are in this group, how well anal swabs can screen for these lesions, and how having HSIL affects their quality of life. We'll also test if DNA methylation testing can give us extra information about the lesions. The main questions the study aims to answer are: * How common are HSIL in MSM using PrEP? * How accurate are anal swabs for detecting HSIL in this group? * How does having HSIL affect the quality of life of MSM using PrEP? * Can DNA methylation testing help improve our understanding of HSIL in these individuals? Participants will: * Answer questions about their health and quality of life. * Have an anal smear collected for testing. * Undergo High-Resolution Anoscopy (HRA) to check for HSIL and get a biopsy if deemed necessary.

Key facts

Study ID

NCT07029152

Run by

Universitair Ziekenhuis Brussel

People needed

296

Starts

2025-09-23

Expected to finish

2026-12-01

Last updated by the study team

2026-05-01

Who can join

Age: 35 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• CHU Charleroi - Chimay — Lodelinsart, Belgium (enrolling)
• CHU Saint-Pierre — Brussels, Belgium (enrolling)
• Cliniques universitaires Saint-Luc - UCLouvain — Brussels, Belgium (enrolling)
• UZ Brussel — Brussels, Belgium (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• Jessaziekenhuis — Hasselt, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium
• AZ Sint Jan — Bruges, Belgium

Full record on ClinicalTrials.gov

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