ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
NCT ID: NCT07151118
Last Updated: 2025-09-09
Study Results
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Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-09-01
2027-08-31
Brief Summary
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Detailed Description
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Circulating tumor DNA (ctDNA) has emerged as a promising biomarker for molecular profiling, treatment monitoring, and prognosis assessment. Prior studies demonstrated acceptable concordance between ctDNA-based and tissue-based next-generation sequencing, particularly for FGFR2 fusions, and highlighted the potential of ctDNA in identifying additional genomic alterations not detected in tissue samples.
This prospective study will enroll 100 Korean patients with advanced or metastatic BTC from 11 hospitals. Approximately two-thirds of patients will provide blood samples prior to first-line systemic therapy, while one-third will provide samples before subsequent therapy. Additional blood draws will be performed at progression in patients harboring FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be analyzed by a central laboratory (SCL Healthcare, a precision medicine service provider specializing in biomarker-based diagnostics).
The primary objective is to evaluate the frequency of actionable genomic alterations, especially FGFR2 fusions, detected by ctDNA in advanced BTC patients. Secondary objectives include:
* Assessing the concordance between ctDNA and tissue genomic profiling
* Evaluating the proportion of patients who received targeted therapy based on ctDNA results (e.g., pemigatinib \[Pemazyre®\])
* Exploring associations between ctDNA maximum variant allele frequency (max VAF) and survival outcomes
* Identifying potential resistance mechanisms and clonal evolution during targeted therapy
This study is expected to provide robust evidence for the clinical utility of ctDNA in BTC and contribute to the establishment of precision medicine approaches, potentially supporting future guideline development and regulatory approval of ctDNA assays in Korea and globally.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Blood Sampling for ctDNA Analysis
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.
Interventions
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Blood Sampling for ctDNA Analysis
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to provide written informed consent
19 Years
ALL
No
Sponsors
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Handok Inc.
INDUSTRY
CHA University
OTHER
Responsible Party
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Hong Jae Chon
Principal Investigator
Principal Investigators
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Hong Jae Chon
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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References
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Other Identifiers
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CHAMC2025-03-041
Identifier Type: -
Identifier Source: org_study_id
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