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

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Anal Cancer; Squamous Cell Carcinoma; HPV; HSIL, High Grade Squamous Intraepithelial Lesions; LSIL, Low-Grade Squamous Intraepithelial Lesions; Squamous Intraepithelial Lesions

Treatments: Diagnostic Test: Anal smear; Behavioral: EQ-5D-5L questionnaire; Diagnostic Test: High Resolution Anoscopy (HRA); Behavioral: Self-administered questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT07029152

SCOPE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 296 estimated patients

Sex: Male

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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296 participants in 1 patient group

MSM group

Experimental 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)

Treatment:

Behavioral: Self-administered questionnaire

Diagnostic Test: High Resolution Anoscopy (HRA)

Behavioral: EQ-5D-5L questionnaire

Diagnostic Test: Anal smear