Clinical Trial

ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-25; most recent amendment 2026-03-17.
Status change: Not Yet Recruiting → Recruiting 2026-03-17
Trial Details
NCT Number NCT07151118
Lead Sponsor CHA University
Collaborators: Handok Inc.
Conditions Biliary Tract Cancer
Enrollment 100 participants
Start Date 2025-09-01
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-18