Actively Recruiting
A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening
Led by Yingbin Liu, MD, PhD, FACS · Updated on 2025-09-16
1800
Participants Needed
1
Research Sites
330 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), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.
CONDITIONS
Official Title
A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate voluntarily and able to follow study procedures; if unable to consent, a legal representative can sign
- Age between 18 and 80 years inclusive
- Able to provide blood samples as required
- Pathologically confirmed biliary tract carcinoma (stages I-IV) or other specified gastrointestinal cancers or clinically diagnosed benign biliary diseases
- Stable vital signs with ECOG performance status 0-1
- Adequate organ function as measured by liver enzymes, blood counts, kidney function, and bilirubin levels
- For external validation, patients with imaging or lab findings suspicious for BTC with planned surgery or biopsy
- Healthy volunteers able to consent and provide blood samples, age 18-80 years inclusive
You will not qualify if you...
- Pregnant or breastfeeding women
- History of organ or allogeneic bone marrow/stem cell transplantation
- Blood transfusion within 7 days before blood collection
- History of or ongoing curative cancer treatment within 3 years before blood collection
- Use of anti-tumor drugs within 30 days before blood collection
- Known bleeding disorders or autoimmune diseases
- Concurrent other malignancies or multiple primary tumors
- For non-cancer participants, history of any malignant tumor or clinically significant health abnormalities (excluding minor conditions)
- For external validation, pathology confirmed benign disease after biopsy/surgery or failure to confirm malignancy within 42 days after blood collection
- Special exclusion for precancerous lesions or prior anti-tumor therapy before blood collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
Y
Yingbin Liu, PhD
CONTACT
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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