deltatrials
Recruiting INTERVENTIONAL NCT07029152

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

Screening for Anal Cancer in MSM Using PrEP

Sponsor: A.M.L.

Conditions Anal Cancer HPV HSIL, High Grade Squamous Intraepithelial Lesions LSIL, Low-Grade Squamous Intraepithelial Lesions Squamous Cell Carcinoma Squamous Intraepithelial Lesions
Interventions Anal smear EQ-5D-5L questionnaire High Resolution Anoscopy (HRA) Self-administered questionnaire
Updated 4 times since 2025 Last updated: Apr 30, 2026 Started: Sep 23, 2025 Primary completion: Dec 1, 2026 Completion: Dec 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07029152, this observational or N/A phase trial focuses on Anal Cancer and HPV and remains actively recruiting participants. Sponsored by A.M.L., it has been updated 4 times since 2025, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

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...

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.

Status Flow

~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshotNot Yet Recruiting~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotNot Yet Recruiting~Dec 2025 – ~May 2026 · 5 months · monthly snapshotRecruitingMay 4, 2026 – present · 2 months · daily APIRecruiting

Change History

4 versions recorded

  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: NA → None

  2. Dec 2025 — May 2026 [monthly]

    Recruiting NA

    Status: Not Yet Recruiting → Recruiting

  3. Sep 2025 — Dec 2025 [monthly]

    Not Yet Recruiting NA

  4. Jul 2025 — Sep 2025 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • A.M.L.
  • Universitair Ziekenhuis Brussel
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations