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

Sponsor
CHA University
Study ID
NCT07151118
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Blood Sampling for ctDNA Analysis — OTHER
    Approximately 20 mL of peripheral blood will be collected from patients with advanced biliary tract cancer. Samples will be obtained prior to systemic therapy initiation (in about two-thirds of patients) or prior to subsequent therapy (in about one-third of patients). Additional blood draws may be performed at progression in patients with FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be centrally analyzed for genomic alterations using ctDNA profiling.

Study Details

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 Dates

First listed
Sep 3, 2025
Start date
Sep 1, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Advanced Biliary Tract Cancer Patients
    Patients with histologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer). Participants will provide blood samples for circulating tumor DNA (ctDNA) analysis before systemic therapy or prior to subsequent treatment.

Primary Outcome Measure

Detection of Actionable Genomic Alterations by ctDNA Profiling [ Time Frame: Baseline (within 30 days prior to initiation of systemic therapy or prior to subsequent treatment) ]

Central Contacts

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