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Clinical Trial Record

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

2023-11-01

2025-06-30

2025-12-31

1608

Study Overview

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

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.

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.

  • Liver Cancer
  • Biliary Tract Cancer
  • Pancreatic Cancer
  • DIAGNOSTIC_TEST: Blood drawing
  • 2023-0871

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-11-14  

N/A  

2025-02-05  

2023-11-14  

N/A  

2025-02-10  

2023-11-18  

N/A  

2025-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers.24 months
Secondary Outcome MeasuresMeasure DescriptionTime 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yuan Ding, Phd

Phone Number: +8657187783820

Email: dingyuan@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
40 Years

Accepts Healthy Volunteers:
1

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Guangzhou Burning Rock Dx Co., Ltd.
  • STUDY_CHAIR: Weilin Wang, Phd, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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