Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID07176962

A Cell-free DNA Methylation Liquid Biopsy for Diagnosis and Management of Biliary Tract Cancers

Led by Yingbin Liu, MD, PhD, FACS · Updated on 2025-09-16

1800

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

Sponsors

Y

Yingbin Liu, MD, PhD, FACS

Lead Sponsor

Q

Qilu Hospital of Shandong University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Biliary tract carcinoma (BTC) includes cancers of the gallbladder, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma. It is a highly aggressive cancer with poor outcomes, ranking sixth in gastrointestinal cancer incidence and tenth in cancer-related deaths worldwide. Because early symptoms are often absent and the disease tends to recur and spread, only about 16.5% of patients can have curative surgery, and the overall 5-year survival rate is under 5%. Early and accurate detection is crucial to improve patient outcomes. This research aims to assess the use of cell-free DNA (cfDNA) methylation in blood as a liquid biopsy for diagnosing and managing BTC. The study involves several groups, including healthy individuals, patients with confirmed benign biliary lesions, other gastrointestinal cancers, and those with confirmed or suspected BTC. Researchers will analyze methylation patterns in circulating tumor DNA (ctDNA), a small fraction of cfDNA that carries tumor genetic and epigenetic information. This approach is studied for its potential to detect BTC early, assist in differential diagnosis, monitor prognosis, and guide therapy. Different cohorts serve as internal training, validation sets, and independent validation groups. Participants will provide blood samples and undergo clinical evaluations to measure the accuracy of the ctDNA methylation test in diagnosing BTC. The study will assess diagnostic performance by cancer subtype and stage, and ability to distinguish BTC from other conditions. Vital signs, organ function, and other health markers will be monitored to ensure participant safety. The study welcomes adults aged 18 to 80 years, with follow-up and assessments continuing until May 2026 to evaluate the test's clinical utility.

CONDITIONS

Brief Title

A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years inclusive
  • Willing and able to participate and comply with study procedures
  • Able to provide required blood samples
  • Pathologically confirmed biliary tract carcinoma (TNM stage I-IV) or other gastrointestinal malignancies (hepatocellular carcinoma, gastric cancer, colorectal cancer, pancreatic cancer) or benign biliary diseases
  • Stable vital signs with ECOG performance status 0-1
  • Adequate organ function with specific lab criteria for liver enzymes, blood counts, kidney function, and bilirubin
  • For healthy volunteers, able to provide informed consent and blood samples
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation
  • Blood transfusion within 7 days prior to blood collection
  • History of curative cancer treatment within 3 years prior to blood collection
  • Use of anti-tumor drugs within 30 days prior to blood collection
  • Known bleeding disorders or autoimmune diseases
  • Concurrent other malignancies or multiple primary tumors
  • Clinically significant abnormalities on routine exams (excluding certain benign conditions)
  • Failure to confirm malignancy by pathology or imaging within 42 days after blood collection
  • Pathology confirmed precancerous lesions or benign disease after biopsy/surgery
  • Special exclusions for healthy volunteers including history of malignant tumors or significant health abnormalities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessments only

Participants provide blood samples to evaluate ctDNA methylation markers for diagnosing biliary tract cancers and differentiating from benign or other gastrointestinal conditions.

1 visit (in-person) for blood collection

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored over time to assess diagnostic performance and disease progression through blood-based methylation testing.

Periodic blood sample collections may occur depending on clinical need

Trial Site Locations

Total: 1 location

1

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

Y

Yingbin Liu, 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

4

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