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Clinical Trial NCT07176962 for Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc), Extrahepatic Cholangiocarcinoma, Hilar Cholangiocarcinoma, Billiary Track Cancer, ctDNA is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Cell-free DNA Methylation Blood-Based Test for Biliary Tract Cancers Screening 1,800 Biomarker-Driven

Recruiting
Clinical Trial NCT07176962 is an observational study for Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc), Extrahepatic Cholangiocarcinoma, Hilar Cholangiocarcinoma, Billiary Track Cancer, ctDNA that is recruiting. It started on January 1, 2020 with plans to enroll 1,800 participants. Led by Yingbin Liu, MD, PhD, FACS, it is expected to complete by May 1, 2026. The latest data from ClinicalTrials.gov was last updated on September 16, 2025.
Brief Summary
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 sur...Show More
Detailed Description
Biliary tract carcinoma (BTC), encompassing gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, is an aggressive malignancy with poor prognosis. Globally, it ranks sixth in incidence among gastrointestinal cancers and tenth in cancer-related mortality. BTC is characterized by the absence of specific early symptoms, high degree of malignancy, and a strong tendency for recurrence a...Show More
Official Title

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

Conditions
Gall Bladder CancerIntrahepatic Cholangiocarcinoma (Icc)Extrahepatic CholangiocarcinomaHilar CholangiocarcinomaBilliary Track CancerctDNA
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • BTC_ctDNAm_LYB_2025
NCT ID Number
NCT07176962
Start Date (Actual)
2020-01-01
Last Update Posted
2025-09-16
Completion Date (Estimated)
2026-05-01
Enrollment (Estimated)
1,800
Study Type
Observational
Status
Recruiting
Keywords
ctDNA methylation
Early diagnosis
Liquid biopsy
Billiary Track Cancer
Arms / Interventions
Participant Group/ArmIntervention/Treatment
control（Internal training and validation sets）
Healthy individuals Patients with pathologically confirmed benign biliary lesions Patients with other gastrointestinal malignancies
N/A
malignant（Internal training and validation sets）
patients with intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer
N/A
malignant (Independent validation set)
patients with suspected biliary tract malignancies
N/A
control (Independent validation set)
Healthy individuals
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnostic performance of the ctDNA methylation model in biliary tract cancer
Evaluate the overall sensitivity, specificity, and accuracy of the ctDNA methylation liquid biopsy model in the diagnosis of biliary tract cancer (BTC).
Baseline
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Subtype-specific diagnostic performance
Sensitivity, specificity, and accuracy of the ctDNA methylation model in gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma.
Baseline
Stage-specific diagnostic performance
Sensitivity, specificity, and accuracy of the model across BTC stages I-IV (TNM staging).
Baseline
Differential diagnosis
Sensitivity, specificity, and accuracy of the ctDNA methylation model in distinguishing BTC from benign biliary lesions.
Baseline
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

  • BTC patients

    1. Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).
    2. Age 18-80 years (inclusive).
    3. Able to provide required blood samples.
    4. Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).
    5. Stable vital signs; ECOG performance status 0-1.
    6. Adequate organ function: AST/ALT ≤ 5 × ULN; Child-Pugh class A or B; WBC > 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 60 mL/min; Total bilirubin ≤ 3 × ULN.

  • Other gastrointestinal malignancies (to exclude BTC non-specific signals)

    1. Voluntary participation with signed informed consent (or by LAR).
    2. Age 18-80 years (inclusive).
    3. Able to provide required blood samples.
    4. Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).
    5. Stable vital signs; ECOG performance status 0-1.

  • Non-cancer participants (benign biliary disease)

    1. Able to provide written informed consent.
    2. Able to provide required blood samples.
    3. Age 18-80 years (inclusive).
    4. Pathologically or clinically diagnosed benign biliary diseases, including cholecystitis, cholelithiasis, choledocholithiasis, adenomyomatosis, gallbladder polyps, xanthogranulomatous cholecystitis, or primary sclerosing cholangitis.

External Validation Cohorts

  • BTC patients

    1. Voluntary participation with signed informed consent (or by LAR).
    2. Imaging findings of malignant biliary stricture or mass, or serum CA19-9 > 100 U/mL, highly suspicious for BTC, with planned surgery or biopsy for pathological confirmation.
    3. Age 18-80 years (inclusive).
    4. Able to provide required blood samples.
    5. Stable vital signs; ECOG performance status 0-1.
    6. Adequate organ function: AST/ALT ≤ 5 × ULN; Child-Pugh class A or B; WBC > 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 60 mL/min; Total bilirubin ≤ 3 × ULN.

  • Healthy volunteers

    1. Able to provide written informed consent.
    2. Able to provide required blood samples.
    3. Age 18-80 years (inclusive).

  • Cancer patients

    1. Pregnant or breastfeeding women.
    2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
    3. Blood transfusion within 7 days prior to blood collection.
    4. History of curative cancer treatment within 3 years prior to blood collection.
    5. Use of anti-tumor drugs within 30 days prior to blood collection.
    6. Known bleeding disorders.
    7. Known autoimmune diseases.
    8. Concurrent other malignancies or multiple primary tumors.

  • Non-cancer participants

    1. Pregnant or breastfeeding women.
    2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
    3. Blood transfusion within 7 days prior to blood collection.
    4. History of any malignant tumor.
    5. Known bleeding disorders.
    6. Known autoimmune diseases.
    7. Clinically significant abnormalities on routine examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).

External Validation Cohorts

  • Cancer patients

    1. Pregnant or breastfeeding women.
    2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
    3. Blood transfusion within 7 days prior to blood collection.
    4. History of or ongoing curative cancer treatment within 3 years prior to blood collection.
    5. Use of anti-tumor drugs within 30 days prior to blood collection.
    6. Known bleeding disorders or autoimmune diseases.
    7. Concurrent other malignancies (including multiple primaries) or known cancer susceptibility gene carriers.
    8. Pathology confirmed benign disease after biopsy/surgery.
    9. Failure to confirm malignancy by pathology or imaging within 42 days after blood collection, or unclear lesion site/evidence.
    10. Special exclusion criteria:

  • Pathology confirmed precancerous lesions.

  • Any local/regional or systemic anti-tumor therapy (including surgery, radiotherapy, targeted therapy, or immunotherapy) prior to blood collection.

  • Healthy volunteers

    1. Pregnant or breastfeeding women.
    2. History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
    3. Blood transfusion within 7 days prior to blood collection.
    4. History of any malignant tumor.
    5. Known bleeding disorders or autoimmune diseases.
    6. Clinically significant abnormalities on health examination (excluding hepatitis, hepatic cysts, or benign pulmonary nodules).
Yingbin Liu, MD, PhD, FACS logoYingbin Liu, MD, PhD, FACS
Study Responsible Party
Yingbin Liu, MD, PhD, FACS, Sponsor-Investigator, principal investigator, Shanghai Jiao Tong University School of Medicine
Study Central Contact
Contact: Yingbin Liu, PhD, +86 13918803900, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, Shanghai Municipality, 200127, China
Yingbin Liu, PhD, Contact, +86 13918803900, [email protected]
Recruiting