Biliary Tract Cancer, Liver Cancer, Pancreatic Cancer
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTBlood drawing
The participants had their blood drawn.
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers. | 24 months |
Secondary
| Measure | Time 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 |
Countries
China
Contacts
Primary ContactYuan Ding, Phd
Outcome results
None listed