Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Ruijin Hospital
- Enrollment
- 7062
- Locations
- 3
- Primary Endpoint
- The performance of the cfDNA methylation-based model in pancreatic cancer early detection in participants at high risk for pancreatic cancer.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
ASCEND-PANCREATIC is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, circulating tumor DNA (ctDNA) mutation, serum protein markers and blood miRNA markers, in which of 7,062 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 healthy individuals. The performance of the pancreatic cancer detection test will be evaluated in participants with high risk of pancreatic cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The performance of the cfDNA methylation-based model in pancreatic cancer early detection in participants at high risk for pancreatic cancer.
Time Frame: 90 months
Sensitivity and specificity of the cfDNA methylation-based model in detecting pancreatic cancer.
Time Frame: 30 months
Secondary Outcomes
- The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages.(30 months)
- Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers.(30 months)
- Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting pancreatic cancer, respectively.(30 months)