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

NCT07029152 | Recruiting

• 1 other identifier: SCOPE
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

HIV prevention; men who have sex with men; pre-exposure prophylaxis (PrEP); anal cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium

  The primary endpoint aims to determine the prevalence of HR HPV in MSM-PrEP in Belgium.

  From screening to study completion for the patient (on average 8 months).

Secondary Outcomes (8)

• Prevalence of abnormal anal cytology in MSM using PrEP in Belgium

  From screening to study completion for the patient (on average 8 months).

• Prevalence of abnormal histology, i.e. LSIL and HSIL in MSM using PrEP in Belgium

  From screening to study completion for the patient (on average 8 months).

• Methylation on cytology (screening) samples and histology (HRA) samples

  From screening to study completion for the patient (on average 8 months).

• Accuracy of anal HPV genotyping, anal cytology and methylation, together or as separate tests in the prediction of hHSIL

  From screening to study completion for the patient (on average 8 months).

• Can we distinguish different profiles in hHSIL suggesting repression or progression?

  From screening to study completion for the patient (on average 8 months).

Study Arms (1)

MSM group

EXPERIMENTAL

The MSM group consists of men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) for HIV prevention. Participants in this group will undergo the following interventions: * Health and Quality of Life Questionnaires * Anal Smear Collection * High-Resolution Anoscopy (HRA)

Diagnostic Test: Anal smear; Behavioral: Self-administered questionnaire; Behavioral: EQ-5D-5L questionnaire; Diagnostic Test: High Resolution Anoscopy (HRA)

Interventions

Anal smear DIAGNOSTIC_TEST

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

MSM group

Self-administered questionnaire BEHAVIORAL

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.

MSM group

EQ-5D-5L questionnaire BEHAVIORAL

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.

MSM group

High Resolution Anoscopy (HRA) DIAGNOSTIC_TEST

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.

MSM group

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• A.M.L.: collaborator

Study Sites (8)

AZ Sint Jan

Bruges, 8000, Belgium

ACTIVE NOT RECRUITING

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Cliniques universitaires Saint-Luc - UCLouvain

Brussels, 1200, Belgium

RECRUITING

UZ Brussel

Brussels, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

Jessaziekenhuis

Hasselt, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

ACTIVE NOT RECRUITING

CHU Charleroi - Chimay

Lodelinsart, 6042, Belgium

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms; Squamous Intraepithelial Lesions; Carcinoma, Squamous Cell; Homosexuality

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Sexuality; Sexual Behavior; Behavior

Central Study Contacts

Magali Surmont

CONTACT

024776001; magali.surmont@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 19, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-10

Locations

BE (8)