Clinical trial · Interventional
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
Screening for Anal Cancer in MSM Using PrEP
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| HPV | — | UNRESOLVED | — |
| HSIL, High Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| LSIL, Low-Grade Squamous Intraepithelial Lesions | Low Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anal smear | Diagnostic Test | — | UNRESOLVED |
| EQ-5D-5L questionnaire | Behavioral | — | UNRESOLVED |
| High Resolution Anoscopy (HRA) | Diagnostic Test | — | UNRESOLVED |
| Self-administered questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MSM group
- description
- 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)
- interventionNames
- Diagnostic Test: Anal smear
- Behavioral: Self-administered questionnaire
- Behavioral: EQ-5D-5L questionnaire
- Diagnostic Test: High Resolution Anoscopy (HRA)
Primary outcomes (1)
- measure
- Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium
- timeFrame
- From screening to study completion for the patient (on average 8 months).
- description
- The primary endpoint aims to determine the prevalence of HR HPV in MSM-PrEP in Belgium.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available