DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years or older
- •Signed an approved informed consents
- •Feasible to be followed up
- •Available residual cytology samples for methylation analysis
排除标准
- •Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
- •No requirement of cervical cancer screening of cytology or high-risk human papillomavirus
研究组 & 干预措施
Study group
All eligible participants are included in the study group
干预措施: Host DNA methylation testing (Diagnostic Test)
Study group
All eligible participants are included in the study group
干预措施: Cervical cytology and/or high-risk human papillomavirus assays (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy
时间窗: Two years
The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
次要结局
未报告次要终点
研究者
Lei Li
Professor
Peking Union Medical College Hospital