NCT04820868已完成不适用
A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 2,508 人开始时间: 2021年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,508
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model
研究概览
简要总结
According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model
时间窗: 7 months
次要结局
- Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer(7 months)
研究者
研究点 (1)
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