Early-stage Detection of LIver, Biliary tRAct and pancReatic Cancers

Pancreatic Cancer Clinical Trial

Official title:

Early-stage Detection of LIver, Biliary tRAct and pancReatic Cancers by Liquid biopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139042
• Other study ID #: 2023-0871
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuan Ding, Phd
• Phone: +8657187783820
• Email: dingyuan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1608
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Liver Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Blood drawing
The participants had their blood drawn.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers.		24 months
Secondary	The sensitivity and specificity of the combined model in detection of different subtypes of cancers.		24 months
Secondary	The sensitivity and specificity of the combined model in detection of different stages of liver, biliary tract and pancreatic cancers.		24 months