ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
Recruiting now
Conditions studied: Biliary Tract Cancer
In brief
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.
Key facts
- Study ID
- NCT07151118
- Run by
- CHA University
- People needed
- 100
- Starts
- 2025-09-01
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-03-18
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Refusal to provide blood samples for ctDNA testing
- Inability to provide written informed consent
Where it is running
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
Full record on ClinicalTrials.gov
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