Status:
COMPLETED
Biomarker Discovery in Patients With Advanced Biliary Tract Cancer
Lead Sponsor:
CHA University
Collaborating Sponsors:
Dong-A Pharmaceutical
Conditions:
Biliary Tract Cancer
Cholangiocarcinoma
Eligibility:
All Genders
19+ years
Brief Summary
Biliary tract cancer is a rare gastrointestinal malignant neoplasm and includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer. Curative surgical resection o...
Detailed Description
Using biopsy specimen (formalin fixed paraffin embedded tissue), in-house NGS and RNA-sequencing will be performed simultaneously. Through this, investigators will discover biomarkers based on multi-o...
Eligibility Criteria
Inclusion
- Age ≥ 19 years old
- Capable of understanding and complying with the protocol requirements and signed informed consent
- The patients were confirmed as bilary tract cancer (gall bladder cancer, extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma) by histopathology or cytology
- Patients with inoperable or metastatic or recurrent biliary tract cancer
- Patients who underwent in-house next-generation sequencing
- Patients planning to receive Gemcitabine, Cisplatin, nab-paclitaxel triplet chemotherapy
- At least one measurable objective lesion was identified based on the RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- The expected survival a ≥3 months
Exclusion
- The subject has uncontrolled, significant intercurrent or recent illness including infection for organ failure
- Prior palliative chemotherapy for biliary tract cancer
- Dementia, altered mental state, or any mental illness that prevents understanding or informed consent
- Other conditions that researchers not think to be suitable for enrollment.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04871321
Start Date
April 14 2021
End Date
December 31 2023
Last Update
August 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496