Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC

Sponsor
CHA University
Study ID
NCT07142226
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS)) — GENETIC
    Peripheral blood will be collected from patients with advanced biliary tract cancer for circulating tumor DNA (ctDNA) testing. Next-generation sequencing (NGS) will be performed to detect clinically relevant genomic alterations, including IDH1 mutations, FGFR2 fusions, ERBB2 amplifications, and MSI-H/dMMR. The ctDNA results will be compared with tissue-based genomic profiling to evaluate concordance and clinical utility.

Study Details

Biliary tract cancer (BTC) is a rare and heterogeneous disease with high incidence and mortality in Korea. Molecular profiling has enabled the identification of actionable alterations such as Isocitrate Dehydrogenase 1 (IDH1) mutations, FGFR2 fusions, ERBB2 amplifications, and dMMR/MSI-H status. However, the utility of tumor tissue-based next-generation sequencing (NGS) is often limited by difficulties in obtaining adequate tissue samples and the lack of in-house sequencing capacity across many hospitals. Circulating tumor DNA (ctDNA) analysis offers a minimally invasive alternative that can provide rapid and reliable genomic profiling. In a previous study, ctDNA testing showed high concordance with tissue-based genomic profiling for clinically significant alterations, particularly IDH1 mutations, and identified additional mutations not detected in tumor tissue. These findings suggest that ctDNA may expand access to targeted therapies such as ivosidenib . This multicenter, prospective, observational epidemiology study, organized by the Korean Cancer Study Group (KCSG) Biliary Tract Cancer Subcommittee, will evaluate the clinical utility of ctDNA-based genomic profiling in patients with advanced BTC. The study will assess concordance between ctDNA and tumor tissue sequencing, describe the prevalence of actionable alterations, and explore the impact of ctDNA testing on treatment decisions and clinical outcomes. By leveraging a nationwide network of BTC specialists, this study seeks to validate ctDNA as a feasible and scalable tool for precision oncology, supporting timely and personalized therapy for patients with BTC.

Key Dates

First listed
Aug 26, 2025
Start date
Sep 1, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Group 1: Advanced BTC Patients
    Description: Patients with histologically or cytologically confirmed advanced biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who are enrolled prospectively across participating centers in Korea. Number of Participants: 200 (anticipated) Cohort Type: Single observational cohort

Primary Outcome Measure

Concordance Between ctDNA and Tissue-Based Genomic Profiling [ Time Frame: Within 4 weeks of study enrollment, prior to initiation of systemic therapy ]

Central Contacts

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