Natural History of Anal Human Papillomavirus Infection and Associated Disease in HIV-infected Men Who Have Sex With Men: Towards an Evidence Base for the Prevention of Anal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Evaluation of high-grade anal lesions by high resolution anoscopy
研究概览
简要总结
Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution.
Estimated enrolment: 500
Principal Outcomes
- Detection of high-grade cytological and histological anal lesions by high resolution anoscopy
- Spontaneous regression of high-grade anal lesions
- Detection of anal HPV infection
Intervention (procedure):
- Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
- Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
- High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):
- anal biopsy(ies) during HRA
Only if high-grade lesion:
- HRA biannually
详细描述
Intervention (procedure):
- Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
- Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
- High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):
- anal biopsy(ies) during HRA
Only if high-grade lesion (Atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (ASC-H), High grade Superficial Intra-epithelial Lesion (HSIL) or AIN2/3):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who have sex with men
- •At least 35 years old
- •HIV-positive (documented search of HIV infection, with HIV status determined according to HAS algorithm)
- •Signed informed consent
- •Affiliated to or beneficiary of French social security
- •All severity criteria and evolution of HIV disease are accepted (including AIDS stage and co-infections)
排除标准
- •Contraindication to biopsy
- •History of anal cancer or pelvic radiotherapy
- •AIN2/3 treated during previous year
- •Current anticancer chemotherapy or within 24 months before inclusion
- •Difficulty in evaluation (anus reshaped and/or scarred)
- •Individual placed under judicial protection
- •Foreseen absence which may hamper participation; insufficient motivation; associated pathology with priority for care
结局指标
主要结局
Evaluation of high-grade anal lesions by high resolution anoscopy
时间窗: Initial inclusion visit
Quantification of spontaneous regression of high-grade anal lesions
时间窗: Month 24
Evaluation of anal HPV infection by DNA, RNA and protein detection
时间窗: Initial inclusion visit
次要结局
- Evaluation of anal HPV infection by DNA, RNA and protein detection(Month 24)