AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies
Completed
- Conditions
- Hepatobiliary Malignancies
- Interventions
- Device: Multi-cancer early detection test
- Registration Number
- NCT04835675
- Lead Sponsor
- Zhujiang Hospital
- Brief Summary
This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Benign Diseases Arm Multi-cancer early detection test Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected Cancer Arm Multi-cancer early detection test Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected
- Primary Outcome Measures
Name Time Method Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98% 16 months Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers 16 months
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages 16 months Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system 16 months Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers 16 months Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies 16 months
Trial Locations
- Locations (1)
Zhujiang Hospital
🇨🇳Guangzhou, Guangdong, China