Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Guangzhou Burning Rock Dx Co., Ltd.
- Enrollment
- 14026
- Locations
- 3
- Primary Endpoint
- The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.
- Last Updated
- 5 years ago
Overview
Brief Summary
PREDICT is a prospective, multi-center 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 early stage 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
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.
Time Frame: 32 months
The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.
Time Frame: 32 months
Secondary Outcomes
- The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.(32 months)
- The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.(32 months)
- The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.(32 months)
- The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.(32 months)