Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2023-11-01
Last updated
2025-02-10
Condition(s) studied
Liver CancerBiliary Tract CancerPancreatic Cancer
Investigational drug(s) / intervention(s)
Blood drawing
Blood drawing: The participants had their blood drawn.
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers. — 24 months
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.