Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)
研究概览
简要总结
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
详细描述
The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy.
The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Also, the study proposes to:
- study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after.
- study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study
- compare HRA results with anal cytology results
- compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial.
- study factors associated with the presence of HSIL and/or anal cancer.
- compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;
- •Informed and written signed consent
- •Participant with regular health insurance
排除标准
- •Participant under guardianship or curatorship
- •Participant with free State medical assistance
- •Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.
结局指标
主要结局
High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)
时间窗: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.
次要结局
- HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome(at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.)
- Nature of abnormalities on anal histology of lesions: location, type, grade(10 years after participation in the ANRS IPERGAY trial)
- Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.(10 years after participation in the ANRS IPERGAY trial)
- Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.(at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.)
- Presence of different HPV virus types in the oropharynx(at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.)