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

Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Liver Cancer; Biliary Tract Cancer
• Intervention / Treatment: Diagnostic test: Blood drawing

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 Type: Observational
• Enrollment (Estimated): 1608

Contacts and Locations

• Study Contact: Name: Yuan Ding, Phd; Phone Number: +8657187783820; Email: dingyuan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Weilin Wang, M.D.; Phone Number: +8657187783820; Email: wam@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Our study included participants diagnosed with liver, biliary tract, and pancreatic cancers or benign diseases as well as participants with no known presence of malignancies or benign diseases.

Description

Criteria:

Inclusion Criteria for Cancer Arm Participants:

Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Pathologically confirmed liver, biliary tract and pancreatic cancers. No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw.

Exclusion Criteria for Cancer Arm Participants:

Pregnancy or lactating women. Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.

Recipients of blood transfusion within 7 days prior to study blood draw. Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.

With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Arm Participants:

Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Confirmed diagnosis of benign liver, biliary tract and pancreatic diseases. No prior radical treatment of the benign diseases prior to study blood draw.

Exclusion Criteria for Benign Arm Participants:

Pregnancy or lactating women. Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.

Recipients of blood transfusion within 7 days prior to study blood draw. Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.

Confirmed diagnosis of malignancies or precancerous lesion. A history of malignant tumors.

Inclusion Criteria for Healthy Arm Participants:

• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• No cancer related symptoms within 30 days prior to study screening.
• Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for Healthy Arm Participants:

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 30 days prior to study blood draw.
• Recipient of anti-infectious therapy within 14 days prior to study blood draw.
• Have received or are undergoing curative cancer treatment within three years prior to study screening.
• With autoimmune or other diseases with severe comorbidities.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
liver, biliary tract, and pancreatic cancers; participants with liver, biliary tract, and pancreatic cancers	Diagnostic test: Blood drawing; The participants had their blood drawn.
liver, biliary tract, and pancreatic benign diseases; participants with liver, biliary tract, and pancreatic benign diseases	Diagnostic test: Blood drawing; The participants had their blood drawn.
non-liver, biliary tract, and pancreatic diseases; Participants with no known presence of malignancies or benign diseases	Diagnostic test: Blood drawing; The participants had their blood drawn.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Study Chair: Weilin Wang, Phd, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: 2023-0871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No