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

Recruitingn/aAges 19 Years - anyAllCHA University
NCT07151118 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Refusal to provide blood samples for ctDNA testing * Inability to provide written informed consent
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What it tests

  • Blood Sampling for ctDNA Analysis
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Where

1 site
CHA Bundang Medical Center
Seongnam-si, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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