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NCT07029152Recruiting

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

Screening for Anal Cancer in MSM Using PrEP

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
296 (estimated)
First submitted
2 Jun 2025
Start date
23 Sept 2025
Primary completion date
31 Dec 2026
Lead sponsor
Universitair Ziekenhuis Brussel
Diseases
HIV
NCT number
NCT07029152

What you commit to

  • Study type: Interventional
  • Planned participants: 296
  • From 23 Sept 2025 to the primary completion date, 31 Dec 2026
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • HRA in the last year (anal swab or HRA prior to the last year is no exclusion)

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 35 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AZ Sint Jan
Coordinator of this site? Confirm its status
BrugesBelgiumActive, not recruiting
Cliniques universitaires Saint-Luc - UCLouvain
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
CHU Saint-Pierre
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
UZ Brussel
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting
UZ Gent
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting
Jessaziekenhuis
Coordinator of this site? Confirm its status
HasseltBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumActive, not recruiting
CHU Charleroi - Chimay
Coordinator of this site? Confirm its status
LodelinsartBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.