Testing bile fluid for tumor genetic changes in advanced bile duct and gallbladder cancer
Compares genetic changes found in bile with those in tumor tissue.
Plain-language title generated from the registry record
Registry title: Bile ctDNA Genomic Profiling and Concordance With Tumor Tissue in Biliary Tract Cancer
Key facts
- Where
- Seongnam-si, South KoreaSee the site
Where in South Korea
- CHA Bundang Medical CenterSeongnam-si, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CHA University
- Trial code
- NCT07830628
- Record updated
- 13 October 2026
- Original description
This study is being done to find out whether bile fluid can be used to detect genetic changes in tumors of patients with advanced biliary tract cancer (BTC), such as cancer of the bile ducts or gallbladder.Read full original descriptionShow less
A Prospective Multicenter Observational Study to Evaluate Genomic Profiling of Bile-Derived Circulating Tumor DNA (Bile ctDNA) and Its Concordance With Tumor Tissue DNA in Patients With Advanced Biliary Tract Cancer (BTC)
This study is being done to find out whether bile fluid can be used to detect genetic changes in tumors of patients with advanced biliary tract cancer (BTC), such as cancer of the bile ducts or gallbladder.
Currently, doctors often use a sample of tumor tissue to look for genetic changes that can help guide treatment decisions, including the use of targeted therapies. However, in biliary tract cancer, it can be difficult or risky to collect enough tumor tissue for this kind of testing.
This study will collect a small amount of leftover bile (about 20 mL) during a procedure that patients are already having for medical reasons (such as endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD), which are used to drain bile). A blood sample (about 20 mL) will also be collected at the same time patients are already having blood drawn as part of their regular care. No additional needle sticks or procedures will be done only for this study.
Researchers will analyze the genetic material found in the bile and blood samples and compare the results with the genetic testing already done on the patient's tumor tissue. The main goal is to see how closely the genetic changes found in bile match those found in tumor tissue. The study will also look at whether bile testing can detect genetic changes that may help guide treatment, and whether these results are related to how patients respond to treatment and their long-term outcomes.
About 100 patients with advanced biliary tract cancer will take part in this study at 4 hospitals in South Korea.
Inclusion: Adult male or female patients aged 19 years or older; Histologically confirmed advanced biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer), or clinically suspected biliary tract cancer pending histologic confirmation; Prior to first-line systemic anti-cancer therapy (patients who relapsed ≥6 months after curative surgery or adjuvant chemotherapy are eligible); Tumor tissue next-generation sequencing (NGS) already performed or planned; Willing to provide blood and bile samples for ctDNA analysis.
Exclusion: Patients from whom a bile sample cannot be obtained during clinically indicated biliary drainage (ERCP or PTBD); Patients who decline blood sampling for ctDNA testing; Patients unable to provide informed consent.