Status:
RECRUITING
Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Liver Cancer
Biliary Tract Cancer
Eligibility:
All Genders
40-75 years
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 protei...
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 protei...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1608 Patients enrolled
Trial Details
Trial ID
NCT06139042
Start Date
November 1 2023
End Date
December 31 2025
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009