Actively Recruiting
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
Led by CHA University · Updated on 2026-03-18
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
CHA University
Lead Sponsor
H
Handok Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic biliary tract cancer including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma
- Patients prior to starting first-line systemic therapy or patients who received prior systemic therapy and can provide blood sample before starting subsequent therapy
- Age 19 years or older at enrollment
- Willing and able to provide blood samples for ctDNA analysis
You will not qualify if you...
- Refusal to provide blood samples for ctDNA testing
- Inability to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
Research Team
H
Hong Jae Chon, MD. PhD
CONTACT
H
Hong Jae Chon, MD. PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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