Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers

Recruiting

• Conditions: Biliary Tract Cancer; Liver Cancer; Pancreatic Cancer
• Interventions: Diagnostic Test: Blood drawing

• Registration Number: NCT06139042
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA.

Detailed Description

LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA. The study will enroll approximately 458 participants diagnosed with liver, biliary tract, and pancreatic cancers, 330 individuals with corresponding benign diseases and 820 healthy participants.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1608

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liver, biliary tract, and pancreatic benign diseases	Blood drawing	participants with liver, biliary tract, and pancreatic benign diseases
liver, biliary tract, and pancreatic cancers	Blood drawing	participants with liver, biliary tract, and pancreatic cancers
non-liver, biliary tract, and pancreatic diseases	Blood drawing	Participants with no known presence of malignancies or benign diseases

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers.	24 months

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of the combined model in detection of different subtypes of cancers.	24 months
The sensitivity and specificity of the combined model in detection of different stages of liver, biliary tract and pancreatic cancers.	24 months

Trial Locations

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China