NCT03096938Unknown不适用
Cell-free DNA Methylation Markers for Cancer Screening
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2017年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- sensitivity (true positive rate)
研究概览
简要总结
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is average risk for development of cancer
- •Subject able and willing to undergo screening test within 90 days of enrollment
- •Subject is 40 to 74 years of age inclusive
- •Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
排除标准
- •Subject has any condition which, in the opinion of the investigator should preclude participation in the study
- •Subject has a history of cancer
- •Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
结局指标
主要结局
sensitivity (true positive rate)
时间窗: 2 year
The proportion of persons with disease who have a positive test (positive test results among persons with disease)
Specificity (true negative rate)
时间窗: 2 year
The proportion of persons without disease who have a negative test (negative test results among persons without disease)
次要结局
未报告次要终点
研究者
Ruihua Xu
Prof.
Sun Yat-sen University
研究点 (1)
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