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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 14026
- Locations
- 3
- Primary Endpoint
- Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model
Time Frame: 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
Time Frame: 24 months
Secondary Outcomes
- 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)