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.
BTC patients
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).
Age 18-80 years (inclusive).
Able to provide required blood samples.
Cancer patients
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.
The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Case-control
Other
Not listed
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).
Subtype-specific diagnostic performance
Sensitivity, specificity, and accuracy of the ctDNA methylation model in gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma.
Stage-specific diagnostic performance
Sensitivity, specificity, and accuracy of the model across BTC stages I-IV (TNM staging).
Differential diagnosis
Sensitivity, specificity, and accuracy of the ctDNA methylation model in distinguishing BTC from benign biliary lesions.
Progression-Free Survival (PFS)
To assess the association between ctDNA methylation and PFS in BTC patients.
Overall Survival (OS)
To assess the association between ctDNA methylation and OS in BTC patients.
Recurrence monitoring performance
Sensitivity and specificity of ctDNA methylation for monitoring recurrence and progression of biliary tract malignancies.
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Yingbin Liu, MD, PhD, FACS
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor institution
Qilu Hospital of Shandong University
Collaborator
Xijing Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
West China Hospital
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Hunan Provincial People's Hospital
Collaborator
Fudan University
Collaborator
