Anal CancerSCOPENCT07029152
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
A study testing Anal smear, Self-administered questionnaire and EQ-5D-5L questionnaire in people with Anal Cancer and Squamous Intraepithelial Lesions, run by Universitair Ziekenhuis Brussel at 8 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Anal Cancer, Squamous Intraepithelial Lesions, HSIL, High Grade Squamous Intraepithelial Lesions
- What is being tested?
- Anal smear, Self-administered questionnaire and EQ-5D-5L questionnaire
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 8 sitesBelgium
- Study dates
- 23 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- HRA in the last year (anal swab or HRA prior to the last year is no exclusion)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Belgium8 sites, 6 recruiting
- Active, not recruiting
AZ Sint Jan
Bruges, 8000
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Agnes Libois, dr., +32(0)2/5354130, agnes.libois@stpierre-bru.be
- Recruiting
Cliniques universitaires Saint-Luc - UCLouvain
Brussels, 1200
Leila Belkhir, prof. dr., + 32 2 764 70 87, leila.belkhir@saintluc.uclouvain.be
- Recruiting
UZ Brussel
Brussels
UZ Brussel, 024776001, virgini.vanbuggenhout@uzbrussel.be
- Recruiting
UZ Gent
Ghent, 9000
Marie-Angélique De Scheerder, Prof. dr., +32 (0)9 3322350, MarieAngelique.DeScheerder@UGent.be
- Recruiting
Jessaziekenhuis
Hasselt
Peter Messiaen, 011335014, peter.messiaen@jessazh.be
- Active, not recruiting
UZ Leuven
Leuven, 3000
- Recruiting
CHU Charleroi - Chimay
Lodelinsart, 6042
Remy Demeester, dr., +32 (0)71 922258, remy.demeester@humani.be
About this study
Official title: Screening for Anal Cancer in MSM Using PrEP
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Anal Cancer, Squamous Intraepithelial Lesions, HSIL, High Grade Squamous Intraepithelial Lesions, LSIL, Low-Grade Squamous Intraepithelial Lesions, HPV, Squamous Cell Carcinoma
- Being tested
- Anal smear, Self-administered questionnaire, EQ-5D-5L questionnaire, High Resolution Anoscopy (HRA)
- Keywords
- HIV prevention, men who have sex with men, pre-exposure prophylaxis (PrEP), anal cancer
- Medical subject headings
- Anus Neoplasms, Squamous Intraepithelial Lesions, Carcinoma, Squamous Cell, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal smearDiagnostic 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
Self-administered questionnaireBehavioural
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 questionnaireBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Anal smear; Behavioral: Self-administered questionnaire; Behavioral: EQ-5D-5L questionnaire; Diagnostic Test: High Resolution Anoscopy (HRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary endpoint aims to determine the prevalence of abnormal anal cytology in MSM using PrEP in Belgium
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From screening to study completion for the patient (on average 8 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start23 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- A.M.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029152
- Sponsor's protocol ID
- SCOPE
- Acronym
- SCOPE
- Status last verified
- Oct 2025
- First submitted
- 2 Jun 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Anal Cancer in MSM Using PrEP
- ClinicalTrials.gov ID
- NCT07029152
- Acronym / sponsor ID
- SCOPE / SCOPE
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- A.M.L.
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSM group | Experimental | Diagnostic Test: Anal smear, Behavioral: Self-administered questionnaire, Behavioral: EQ-5D-5L questionnaire, Diagnostic Test: High Resolution Anoscopy (HRA)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) |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- HRA in the last year (anal swab or HRA prior to the last year is no exclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal smearThe 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 | Diagnostic test | MSM group |
| Self-administered questionnaireIt 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. | Behavioural | MSM group |
| EQ-5D-5L questionnaireThis 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. | Behavioural | MSM group |
| 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. | Diagnostic test | MSM group |
Primary outcome
Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium
Time frame: From screening to study completion for the patient (on average 8 months).
The primary endpoint aims to determine the prevalence of HR HPV in MSM-PrEP in Belgium.
8 secondary outcomes
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
Time frame: From screening to study completion for the patient (on average 8 months).
Methylation on cytology (screening) samples and histology (HRA) samples
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
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?
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?
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.
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
Time frame: From screening to study completion for the patient (on average 8 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anal smear, Self-administered questionnaire and EQ-5D-5L questionnaire in people with Anal Cancer and Squamous Intraepithelial Lesions, run by Universitair Ziekenhuis Brussel at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali Surmont (024776001, magali.surmont@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium (time frame: From screening to study completion for the patient (on average 8 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.