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

NCT06139042 | Recruiting DMC

• 1 other identifier: 2023-0871
• Study Type: observational
• Target: 1,608
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Biliary Tract Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers.

  24 months

Secondary Outcomes (2)

• 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

Study Arms (3)

liver, biliary tract, and pancreatic cancers

participants with liver, biliary tract, and pancreatic cancers

Diagnostic Test: Blood drawing

liver, biliary tract, and pancreatic benign diseases

participants with liver, biliary tract, and pancreatic benign diseases

Diagnostic Test: Blood drawing

non-liver, biliary tract, and pancreatic diseases

Participants with no known presence of malignancies or benign diseases

Diagnostic Test: Blood drawing

Interventions

Blood drawing DIAGNOSTIC_TEST

The participants had their blood drawn.

liver, biliary tract, and pancreatic benign diseases; liver, biliary tract, and pancreatic cancers; non-liver, biliary tract, and pancreatic diseases

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Liver Neoplasms; Biliary Tract Neoplasms; Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Weilin Wang, Phd

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yuan Ding, Phd

CONTACT

+8657187783820; dingyuan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)