Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers
Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yuan Ding, Phd
- Phone Number: +8657187783820
- Email: dingyuan@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recruiting
- The Second Affiliated Hospital, Zhejiang University School of Medicine
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Contact:
- Weilin Wang, M.D.
- Phone Number: +8657187783820
- Email: wam@zju.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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liver, biliary tract, and pancreatic cancers
participants with liver, biliary tract, and pancreatic cancers
|
The participants had their blood drawn.
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liver, biliary tract, and pancreatic benign diseases
participants with liver, biliary tract, and pancreatic benign diseases
|
The participants had their blood drawn.
|
|
non-liver, biliary tract, and pancreatic diseases
Participants with no known presence of malignancies or benign diseases
|
The participants had their blood drawn.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The sensitivity and specificity of the combined model in detection of different subtypes of cancers.
Time Frame: 24 months
|
24 months
|
|
The sensitivity and specificity of the combined model in detection of different stages of liver, biliary tract and pancreatic cancers.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Weilin Wang, Phd, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0871
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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