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

Summary

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

• Anal Cancer
• Squamous Intraepithelial Lesions
• HSIL, High Grade Squamous Intraepithelial Lesions
• LSIL, Low-Grade Squamous Intraepithelial Lesions
• HPV
• Squamous Cell Carcinoma

Interventions

DIAGNOSTIC_TEST

Anal smear

The intervention in this study involves the anal smear collection using the FLOQSwab® (COPAN, pouch type 502CS01). The swab is inserted 3-5 cm into the anal canal, reaching the transitional zone, the pressed against the canal wall and withdrawn in a spiral motion over approximately 20 seconds. After collection, the swab is immediately placed into a ThinPrep vial containing 20 ml of PreservCyt® and rinsed vigorously. The procedure is performed by a physician or trained study team member and is designed to be quick, minimally invasive, and comfortable for participants. The FLOQSwab®'s patient-friendly design reduces irritation and false-positive results in comparison to earlier methods. Samples collected in the ThinPrep PreservCyt® solution should be stored at room temperature and transferred to AML within a maximum of six weeks

BEHAVIORAL

Self-administered questionnaire

It includes questions related to: Socio-demographic characteristics Health-related issues Past HPV vaccination (indication? age at vaccination?) History of condylomata and/or other STIs Drug use, tobacco use, alcohol use Anal symptoms: discomfort, itch, pain, nodules, blood loss/discharge, constipation Sexual behavior Insertive/receptive intercourse, chemsex, number of sex partners (stable, occasional, anonymous), condom use.

BEHAVIORAL

EQ-5D-5L questionnaire

This questionnaire will be used after a negative HRA or during the communication of the results (per telephone) and during the treatment if indicated. This questionnaire assesses the impact of health conditions and treatments on person's quality of life. We will use an adapted version of the EQ-5D-5L. This modified version includes additional questions tailored to assess specific domains highlighted in the A-HRSI. The additional items cover: * Physical Symptoms: Question on anal symptoms such as pain, discharge, and burning sensations. * Impact on Physical Functioning: Question on how these symptoms affect daily activities, including work, sitting, and social interactions. * Impact on Psychological Functioning: Question on psychological and sexual well-being, including enjoyment and desire for sex, as well as challenges with intimacy.

DIAGNOSTIC_TEST

High Resolution Anoscopy (HRA)

HRA will be conducted using advanced tools, such as the Zeiss Extaro at UZ Brussel. HRA will be conducted at participating centers with expertise in the technique, including UZ Brussel, UZ Gent, UZ Leuven, UZ Antwerpen, CHU St Pierre, AZ Sint-Jan Brugge, and Citadelle Liège. However, all biopsy specimens will be sent to AML Lab for analysis and stored in the biobank (BB190002). In certain centers, HRA is performed using high-resolution scopes.

Sponsors & Collaborators

• A.M.L.

  collaborator UNKNOWN

• Universitair Ziekenhuis Brussel

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

35 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-23

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Belgium

Study Locations