An interventional study of Anal smear and Self-administered questionnaire in Anal Cancer, Squamous Intraepithelial Lesions and HSIL, High Grade Squamous Intraepithelial Lesions, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 8 sites in Belgium. Open to male participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Screening
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:
Participants will:
This study aims to evaluate High-Grade Squamous Intraepithelial Lesions (HSIL) in men who have sex with men (MSM) using Pre-Exposure Prophylaxis (PrEP) for HIV prevention. MSM are at increased risk for developing anal cancer, and HSIL is a known precursor to this type of cancer. The study seeks to assess the prevalence of HSIL, the screening accuracy of anal swabs, and the impact of HSIL on quality of life for MSM using PrEP. Furthermore, the study will explore the use of DNA methylation testing as a potential tool for improving the detection and understanding of HSIL in this high-risk group.
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.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 296 is above the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
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.
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.
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.
Time frame: From screening to study completion for the patient (on average 8 months).
Prevalence of abnormal anal cytology in MSM using PrEP in Belgium
The secondary endpoint aims to determine the prevalence of abnormal anal cytology in MSM using PrEP in Belgium
Time frame: 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
The third endpoint aims to determine the prevalence of abnormal anal histology in MSM using PrEP in Belgium
Time frame: From screening to study completion for the patient (on average 8 months).
Methylation on cytology (screening) samples and histology (HRA) samples
The fourth endpoint aims to investigate methylation profiles according to the cytological or histo-logical results
Time frame: 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
The fifth endpoint aims to determinate the specificity and sensitivity of anal HPV genotyping, anal cytology and methylation, together and as separate tests, used as screening tests for hHSIL.
Time frame: From screening to study completion for the patient (on average 8 months).
Can we distinguish different profiles in hHSIL suggesting repression or progression?
profiling hHSIL in terms of methylation and biomarkers such as HPV genotyping, HPV-E4, p16 and Ki67
Time frame: From screening to study completion for the patient (on average 8 months).
Can ASCL1/ZNF582 methylation test make accuracy of the less invasive anal swab testing better and/or be used to guide treatment decision making?
Receiver operating curve analysis of anal swabs for hHSIL detection with or without methylation testing on anal swab.
Time frame: From screening to study completion for the patient (on average 8 months).
Determine the incidence of HPV related lesions between demographics, lifestyle, HPV vaccination, sexual risk behavior, history of STI and HPV infection, cytology and histology.
Determination of (multiple) correlations between demographics, lifestyle, HPV vaccination, sexual risk behavior, history of STIs versus HPV infection and abnormal cytohistology.
Time frame: From screening to study completion for the patient (on average 8 months).
Impact of anal cancer screening in MSM using PrEP on quality of life
Determination of quality of life using EQ-5D questionnaire (annex 1) at screening and follow-up in MSM using PrEP.
Time frame: From screening to study completion for the patient (on average 8 months).
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Plan to share: Undecided
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Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 39 interventional studies with no phase under Anus Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 17. This study's planned 15 months is below that.
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