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Recruiting NCT06139042

Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers

— Observational Liver Cancer Biliary Tract Cancer Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood drawing.
Who it may be relevant to
Registry conditions: Liver Cancer, Biliary Tract Cancer, Pancreatic Cancer. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)

Overview

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 test Blood drawing
    The participants had their blood drawn.

Primary outcome measures

  • The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers. [Time frame: 24 months]
Secondary outcome measures (2)
  • The sensitivity and specificity of the combined model in detection of different subtypes of cancers. [Time frame: 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]

Eligibility 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06139042 · 2023-0871

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗