Clinical trial · Observational
Bile ctDNA Genomic Profiling and Concordance With Tumor Tissue in Biliary Tract Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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 ERCP or 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer (BTC) | Malignant Biliary Tract Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bile Sampling for ctDNA Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced Biliary Tract Cancer Patients
- description
- Patients with histologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer). Participants will provide bile samples for circulating tumor DNA (ctDNA) analysis before systemic therapy or prior to subsequent treatment.
- interventionNames
- Other: Bile Sampling for ctDNA Analysis
Primary outcomes (1)
- measure
- Concordance rate of genetic variants between bile ctDNA and tumor tissue DNA
- timeFrame
- Baseline
- description
- Genetic variants detected by next-generation sequencing (NGS) of bile-derived circulating tumor DNA (ctDNA) will be compared with variants identified by tumor tissue NGS performed as part of standard clinical care. Concordance will be assessed using sensitivity and positive predictive value (PPV), with 90% confidence intervals.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (4)
- BACKGROUNDHan JY, Ahn KS, Kim TS, Kim YH, Cho KB, Shin DW, Baek WK, Suh SI, Jang BC, Kang KJ. Liquid Biopsy from Bile-Circulating Tumor DNA in Patients with Biliary Tract Cancer. Cancers (Basel). 2021 Sep 12;13(18):4581. doi: 10.3390/cancers13184581. PMID 34572808
- BACKGROUNDGou Q, Zhang CZ, Sun ZH, Wu LG, Chen Y, Mo ZQ, Mai QC, He J, Zhou ZX, Shi F, Cui W, Zou W, Lv L, Zhuang WH, Xu RD, Li WK, Zhang J, Du HW, Xiang JX, Wang HZ, Hou T, Li ST, Li Y, Chen XM, Zhou ZJ. Cell-free DNA from bile outperformed plasma as a potential alternative to tissue biopsy in biliary tract cancer. ESMO Open. 2021 Dec;6(6):100275. doi: 10.1016/j.esmoop.2021.100275. Epub 2021 Oct 12. PMID 34653800
- BACKGROUNDLi Z, Liu Y, Fu J, Mugaanyi J, Yan J, Lu C, Huang J. Bile is a reliable and valuable source to study cfDNA in biliary tract cancers. Front Oncol. 2022 Aug 26;12:961939. doi: 10.3389/fonc.2022.961939. eCollection 2022. PMID 36091112
- BACKGROUNDHwang S, Woo S, Kang B, Kang H, Kim JS, Lee SH, Kwon CI, Kyung DS, Kim HP, Kim G, Kim C, Chon HJ. Concordance of ctDNA and tissue genomic profiling in advanced biliary tract cancer. J Hepatol. 2025 Apr;82(4):649-657. doi: 10.1016/j.jhep.2024.10.020. Epub 2024 Oct 21. PMID 39442892