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

NCT07176962 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2025-09-16

No results posted yet for this study

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 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

  • Gall Bladder Cancer
  • Intrahepatic Cholangiocarcinoma (Icc)
  • Extrahepatic Cholangiocarcinoma
  • Hilar Cholangiocarcinoma
  • Billiary Track Cancer
  • ctDNA

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Xijing Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Hunan Provincial People's Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Yingbin Liu, MD, PhD, FACS

    lead OTHER

Principal Investigators

  • Yingbin Liu, PhD · RenJi Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2026-03-21
Completion
2026-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176962 on ClinicalTrials.gov