Actively Recruiting

Phase Not Applicable
Age: 35Years +
MALE
NCT07029152

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

Led by Universitair Ziekenhuis Brussel · Updated on 2026-05-01

296

Participants Needed

8

Research Sites

62 weeks

Total Duration

On this page

Sponsors

U

Universitair Ziekenhuis Brussel

Lead Sponsor

A

A.M.L.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 35Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV-uninfected men who have sex with men aged 35 years or older
  • Using PrEP for at least 3 months
  • Able to speak and write Dutch, English, or French
Not Eligible

You will not qualify if you...

  • Any intervention in the anal or peri-anal region within the past 3 months
  • Use of enema within 2 hours before sampling
  • Currently receiving peri-anal topical HPV treatment
  • Had High-Resolution Anoscopy (HRA) within the last year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

AZ Sint Jan

Bruges, Belgium, 8000

Active, Not Recruiting

2

CHU Saint-Pierre

Brussels, Belgium, 1000

Actively Recruiting

3

Cliniques universitaires Saint-Luc - UCLouvain

Brussels, Belgium, 1200

Actively Recruiting

4

UZ Brussel

Brussels, Belgium

Actively Recruiting

5

UZ Gent

Ghent, Belgium, 9000

Actively Recruiting

6

Jessaziekenhuis

Hasselt, Belgium

Actively Recruiting

7

UZ Leuven

Leuven, Belgium, 3000

Active, Not Recruiting

8

CHU Charleroi - Chimay

Lodelinsart, Belgium, 6042

Actively Recruiting

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Research Team

M

Magali Surmont

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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