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Trial Title:
Early-stage Detection of LIver, Biliary tRAct and pancReatic Cancers
NCT ID:
NCT06139042
Condition:
Liver Cancer
Biliary Tract Cancer
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Biliary Tract Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood drawing
Description:
The participants had their blood drawn.
Arm group label:
liver, biliary tract, and pancreatic benign diseases
Arm group label:
liver, biliary tract, and pancreatic cancers
Arm group label:
non-liver, biliary tract, and pancreatic diseases
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The Second Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Weilin Wang, M.D.
Phone:
+8657187783820
Email:
wam@zju.edu.cn
Start date:
November 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Dx Co., Ltd.
Agency class:
Industry
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139042
