A Prospective, Multicenter Study on Development and Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection (Pan-canceR Early DetectIon projeCT, PREDICT Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14,026
- 试验地点
- 3
- 主要终点
- Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model
研究概览
简要总结
PREDICT is a prospective, multicenter study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation-based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.
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
- 是
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 cancer and TOO accuracy of a cfDNA methylation-based model
时间窗: 24 months
Sensitivity of early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants
时间窗: 24 months
次要结局
- Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages of cancer(24 months)
- Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in various types of cancer(24 months)
- Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model, in combination with clinical characteristics and other biomarkers(24 months)