ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorCHA University
About this trial
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 criteria
Qualifiers
Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma)
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
Disqualifiers
Refusal to provide blood samples for ctDNA testing
Inability to provide written informed consent
Trial design
Treatments tested in this trial
- Blood Sampling for ctDNA Analysis
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
CHA University
Lead sponsor
Handok Inc.
Collaborator
Source ClinicalTrials.gov