The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 4
- 主要终点
- A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program
研究概览
简要总结
SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more than 90% of anal cancer.
Gay men are over 20 times more likely than others to develop anal cancer.
SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men.
详细描述
Study title: The natural history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men.
Protocol version: 7, dated 1 September 2013. Approved by Ethics Committee on 24th October, 2013
Objectives: Among homosexual men aged 35 years or above to determine:
- Prevalence, incidence and risk factors for specific types of HPV infection.
- Prevalence, incidence and risk factors for histologically confirmed anal low grade and high grade squamous intraepithelial lesions (LSIL and HSIL).
- Type-specific rates of clearance and persistence of anal HPV infection.
- Rates of disease progression, regression and predictors in the spectrum of anal dysplasia.
- Psychosocial/quality of life impact of anal cytology screening in homosexual men.
Study results will be used to inform possible development of guidelines for carrying out an anal cancer screening program in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Male homosexual aged 35 years or above; HIV positive participants: documented to be HIV positive; HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.
排除标准
- •participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA); unable to understand English; having bleeding disorders or currently taking anti-coagulant medications; having previously received HRA; having ever been diagnosed with anal cancer.
结局指标
主要结局
A natural history study to inform the potential usefulness of a cytology/HPV/HRA based screening program
时间窗: 3 year cohort study
Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)
次要结局
- Prevalence, incidence and risk factors for LSIL and HSIL(3 year cohort study)