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

Study acronym: SCOPE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 7 to 8v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2025 to Sep 23, 2025
    • Site details revised at 7 of 7 sites
    v3
  3. Start date: Jul 2025 to Aug 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07029152
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: A.M.L.
Conditions
(from sponsor)		 Anal Cancer, Squamous Intraepithelial Lesions, HSIL, High Grade Squamous Intraepithelial Lesions, LSIL, Low-Grade Squamous Intraepithelial Lesions, HPV, Squamous Cell Carcinoma
Related terms Anus Neoplasms, Carcinoma, Squamous Cell, Homosexuality, Squamous Intraepithelial Lesions
Enrollment 296 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov