ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - Prospective, Observational, Epidemiology Study
CHA University
100 participants
Sep 1, 2025
OBSERVATIONAL
Conditions
Summary
This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea. Tissue-based genomic profiling is often limited due to the anatomical challenges of tumor biopsy and insufficient DNA quality. ctDNA analysis offers a minimally invasive alternative for identifying actionable genetic alterations, including Fibroblast Growth Factor Receptor 2 (FGFR2) fusions, Isocitrate Dehydrogenase 1 (IDH1) mutations, and Human Epidermal Growth Factor Receptor 2 (HER2) amplifications. The study will recruit 100 patients across 11 institutions and assess the concordance between ctDNA and tissue genomic profiling, as well as the clinical relevance of ctDNA in predicting treatment outcomes and prognosis.
Eligibility
Inclusion Criteria6
- Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma)
- Patients meeting one of the following conditions:
- Prior to initiation of first-line systemic therapy
- Patients who previously received systemic therapy and are able to provide a blood sample prior to initiation of subsequent therapy
- Age ≥ 19 years at the time of enrollment
- Willingness and ability to provide blood samples for ctDNA analysis
Exclusion Criteria2
- Refusal to provide blood samples for ctDNA testing
- Inability to provide written informed consent
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Interventions
Approximately 20 mL of peripheral blood will be collected from patients with advanced biliary tract cancer. Samples will be obtained prior to systemic therapy initiation (in about two-thirds of patients) or prior to subsequent therapy (in about one-third of patients). Additional blood draws may be performed at progression in patients with FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be centrally analyzed for genomic alterations using ctDNA profiling.
Locations(1)
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NCT07151118