Actively Recruiting
Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
1608
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
G
Guangzhou Burning Rock Dx Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting the LIBRARY study, a prospective, multi-center, observational trial focused on detecting early liver, biliary tract, and pancreatic cancers. The study aims to combine tests analyzing cell-free DNA methylation, serum proteins, and microRNA to identify these cancers at early stages. It will include about 458 participants diagnosed with these cancers, 330 with related benign diseases, and 820 healthy individuals. Participants will undergo blood draws for testing the presence of cancer-related markers in their blood. The study involves three participant groups: those with liver, biliary tract, or pancreatic cancers; those with benign diseases of these organs; and healthy volunteers with no known malignancies or benign diseases. The study does not involve treatment interventions but focuses on diagnostic assessments. During the study, participants will provide blood samples that will be analyzed to detect cancer markers. Researchers will measure how accurately the tests identify different cancer types and stages over a 24-month period. Participants will be monitored through scheduled assessments to evaluate the sensitivity and specificity of the blood-based detection methods. The total participation time varies depending on each individual's involvement in the study.
CONDITIONS
Brief Title
Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40-75 years at the day of consenting to the study
- Able to provide a written informed consent
- Pathologically confirmed liver, biliary tract, or pancreatic cancers (for cancer arm)
- No prior or ongoing anti-cancer therapy before study blood draw (for cancer arm)
- Confirmed diagnosis of benign liver, biliary tract, or pancreatic diseases (for benign arm)
- No prior radical treatment of the benign diseases before study blood draw (for benign arm)
- Able to provide sufficient and qualified blood samples for study tests (for healthy arm)
- No cancer-related symptoms within 30 days prior to study screening (for healthy arm)
- Cancer history with curative treatment completed over 3 years without recurrence (for healthy arm)
You will not qualify if you...
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous bone marrow or stem cell transplant
- Recipients of blood transfusion within 7 days prior to study blood draw (for cancer and benign arms)
- Recipients of blood transfusion within 30 days prior to study blood draw (for healthy arm)
- 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 lesions (for benign arm)
- History of malignant tumors (for benign arm)
- Insufficient qualified blood sample for study test (for healthy arm)
- Recipient of anti-infectious therapy within 14 days prior to study blood draw (for healthy arm)
- Received or undergoing curative cancer treatment within three years prior to study screening (for healthy arm)
- Autoimmune or other diseases with severe comorbidities (for healthy arm)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit
Participants provide blood samples for assays to detect early liver, biliary tract, and pancreatic cancers using cell-free DNA methylation, serum protein, and microRNA tests.
1 visit (in-person)
Duration - Up to 24 months
Participants are observed over time to assess the sensitivity and specificity of the detection models for cancers.
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Yuan Ding, Phd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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