Status:
NOT_YET_RECRUITING
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
Lead Sponsor:
CHA University
Collaborating Sponsors:
Handok Inc.
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
19+ years
Brief Summary
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 genom...
Detailed Description
Biliary tract cancer (BTC) is a heterogeneous and aggressive malignancy with poor prognosis, especially in advanced or metastatic stages where surgical resection is not feasible. The current standard ...
Eligibility Criteria
Inclusion
- 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
- Refusal to provide blood samples for ctDNA testing
- Inability to provide written informed consent
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07151118
Start Date
September 1 2025
End Date
August 31 2027
Last Update
September 9 2025
Active Locations (1)
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1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496