Evaluation of Circulating Tumor Mitochondrial DNA as a Biomarker for Minimal Residual Disease and Recurrence Monitoring in Patients with Biliary Tract Cancer

What this Trial Is About

Researchers are investigating the use of circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker to assess minimal residual disease (MRD) and monitor recurrence in patients with biliary tract cancer (BTC). BTC includes cancers such as intrahepatic, perihilar, distal cholangiocarcinomas, and gallbladder cancer. Despite advances in treatment, BTC remains aggressive with poor survival rates, highlighting the need for better monitoring tools. This observational study aims to understand how tumor mitochondrial mutations in plasma relate to the risk of recurrence and overall survival in BTC patients. The study involves collecting plasma samples from BTC patients before and after treatment to analyze mitochondrial DNA mutations using a non-invasive liquid biopsy approach. This method focuses specifically on mitochondrial genomic mutations, which may serve as more sensitive indicators of MRD compared to traditional markers. The study is conducted at a single center by the Chinese Cooperative Group of Liver Cancer and includes detailed mutation analysis to evaluate disease status. Participants will have their plasma samples analyzed for ct-mtDNA mutations at regular intervals to track MRD and disease progression. Researchers will measure progression-free survival (PFS) from treatment start to disease progression or death, with follow-up extending up to two years. Secondary goals include assessing how treatment affects MRD markers, the relationship between residual tumor molecular burden and PFS, and whether MRD detection can predict recurrence earlier than conventional tumor markers or imaging. This study could improve personalized monitoring and treatment decisions for BTC patients.

Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Biliary Tract Cancer Recurrence Surveillance