Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
NCT ID: NCT07029152
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
296 participants
INTERVENTIONAL
2025-09-23
2026-12-31
Brief Summary
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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.
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Detailed Description
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This multicenter clinical trial will involve MSM using PrEP at several study sites to ensure a diverse and representative sample.
The study will focus on prevalence, screening accuracy, and quality of life impacts, and will incorporate DNA methylation testing to explore potential molecular markers for early detection and progression of HSIL.
The primary goal of the study is to improve the early detection of HSIL in MSM using PrEP. By evaluating screening methods and quality of life, this study aims to provide valuable data that could lead to more effective screening strategies and interventions for preventing anal cancer in this population. The use of DNA methylation testing will provide additional insights into the molecular biology of HSIL, potentially informing future screening protocols.
This study addresses a significant gap in current research regarding the prevention and early detection of anal cancer in MSM using PrEP and aims to contribute critical data to improve healthcare outcomes for this high-risk population.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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MSM group
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)
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.
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
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.
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.
Interventions
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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.
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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* participants must have been using PrEP for at least 3 months.
* Dutch, English or French speaking and writing
Exclusion Criteria
* 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)
35 Years
MALE
No
Sponsors
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A.M.L.
UNKNOWN
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Locations
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AZ Sint Jan
Bruges, , Belgium
CHU Saint-Pierre
Brussels, , Belgium
Cliniques universitaires Saint-Luc - UCLouvain
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Charleroi - Chimay
Lodelinsart, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCOPE
Identifier Type: -
Identifier Source: org_study_id
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