Screening for Anal Cancer in MSM Using PrEP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 296
- 试验地点
- 15
- 主要终点
- Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
MSM group
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)
干预措施: Anal smear (Diagnostic Test)
MSM group
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)
干预措施: Self-administered questionnaire (Behavioral)
MSM group
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)
干预措施: EQ-5D-5L questionnaire (Behavioral)
MSM group
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)
干预措施: High Resolution Anoscopy (HRA) (Diagnostic Test)
结局指标
主要结局
Prevalence of anal high-risk HPV infection in MSM-PrEP in Belgium
时间窗: 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.
次要结局
- Prevalence of abnormal anal cytology in MSM using PrEP in Belgium(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(From screening to study completion for the patient (on average 8 months).)
- Methylation on cytology (screening) samples and histology (HRA) samples(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(From screening to study completion for the patient (on average 8 months).)
- Can we distinguish different profiles in hHSIL suggesting repression or progression?(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?(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.(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(From screening to study completion for the patient (on average 8 months).)