Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men - A Danish Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 主要终点
- Anal HSIL prevalence and incidence
研究概览
简要总结
The incidence of anal cancer is increasing, particularly among high-risk groups such as men who have sex with men (MSM), especially those living with HIV. The lack of comprehensive screening programs results in delayed diagnosis and higher mortality.
This project aims to establish a screening program for anal cancer in high-risk populations, with a specific focus on those most at risk. Using a prospective study design, the project will assess the effectiveness of early detection and prevention strategies to potentially reduce cancer incidence and improve survival rates. If an HPV-based screening method proves effective, it would serve as a potential implemention for high-risk groups in Denmark, further enhancing early detection and prevention efforts.
This study represents the first large-scale, prospective screening initiative for anal cancer in Denmark,specifically targeting MSM. It introduces a novel approach to cancer prevention in this population by building on research in other cancers and adapting it to anal cancer and its specific risk factors.
The project is a collaboration between clinical practitioners and academic researchers, ensuring that practical clinical insights guide the research and that research findings are rapidly translated into clinical practice. This partnership will enhance both the quality of the research and its direct application in healthcare.
The project is expected to lead to earlier diagnosis of anal cancer, reduced morbidity and mortality among high-risk populations, and the establishment of a screening model that can be applied nationwide. This could significantly reduce the overall healthcare burden associated with late-stage anal cancer and improve patient outcomes across Denmark.
详细描述
Background:
Anal cancer can potentially be prevented by introducing screening in Denmark. This is in line with the existing cervical cancer screening program available to Danish women aged 23 to 64 since the 1990s.
Anal squamous cell carcinoma (ASCC) is rare in the general population, with an incidence of 1-2 cases per 100,000 (1). In Denmark, approximately 160 new cases of ASCC are diagnosed annually (2), with around 50 fatalities each year. For comparison, there are about 300 cases of cervical cancer in Denmark and 90 related deaths annually. However, the incidence of ASCC has been significantly increasing over the past decades (3) and is expected to rise markedly in the coming years.
More than 80% of the anal cancers are ASCCs. ASCC are preceded by precancerous lesions, anal highgrade squamous intraepithelial lesions (HSIL) (4). ASCC and anal HSIL are caused by persistent infection with high-risk human papilloma virus (hrHPV), found in more than 90% of anal HSIL and ASCC cases, with HPV type 16 being the far most carcinogenic type (5, 6).
Certain populations, including people with HIV and men who have sex with men (MSM), have a significantly higher risk of ASCC and its precancerous lesions (7-10). MSM with HIV constitutes the highest risk of anal cancer with an incidence of anal cancer >70/100,000(1) which is more than 50-times the risk of the general population (10). Pre-exposure prophylaxis (PrEP) is the use of antiviral drugs to protect high-risk populations from acquiring human immunodeficiency virus (HIV) (11). In Denmark, this treatment is offered to people at increased risk of HIV, with the majority being HIV-negative MSM who are engage in high-risk behaviors, such as having multiple sex partners and unprotected anal intercourse and having had recent sexually transmitted infections (STIs) (12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- 是
入选标准
- •MSM with HIV
- •HIV-negative MSMonPrEP
- •Age >=35 years
- •Written and orally informed consent in English or Danish
排除标准
- •Previous anal cancer
- •Rectum extirpation (of any cause)
- •Unwilling to have HRA performed
- •Inflammatory bowel disease
- •Inability and unwillingness to give informed consent
- •Other known immunosuppressive disorder than HIV
- •No sex with men
结局指标
主要结局
Anal HSIL prevalence and incidence
时间窗: 1 year
Anal HSIL defined as the result of findings on HRA confirmed histologically at baseline and 1-year follow-up in HIV positive MSM compared to MSM on PrEP
Anal high-risk HPV infection
时间窗: 1-2 years
Anal HPV infection defined as the result of anal HPV test, including prevalence, incidence, and persistent infections.MSM living with HIV compared to MSM on PrEP
次要结局
- The diagnostic potential of biomarkers (p16/ki67 dual stain cytology, DNA methylation analysis and pHPV).(1-2 years)
- Anal warts prevalence and incidence(1-2 year)
研究者
Helle Kiellberg Larsen
consultant
Bispebjerg Hospital