RecruitingNCT06139042

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)

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

1,608 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

Liver Cancer Pancreatic Cancer Biliary Tract Cancer

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

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria7

Criteria:
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.
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.
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 Criteria13

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.
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.
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.