Biliary Tract Cancer (BTC)NCT07830628
Bile ctDNA Genomic Profiling and Concordance With Tumor Tissue in Biliary Tract Cancer
An observational study of Biliary Tract Cancer (BTC), run by CHA University at 1 site in South Korea.
Trial summary
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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Bile Sampling for ctDNA Analysis
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with advanced (unresectable or metastatic) biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, who are treated at 4 tertiary hospitals in South Korea. Eligible patients are those who are about to undergo clinically indicated biliary drainage (ERCP or PTBD) prior to first-line systemic anti-cancer therapy, from whom residual bile can be collected without any additional invasive procedure. Patients may be enrolled at the time of bile collection even before histologic confirmation of biliary tract cancer; however, only patients with subsequently confirmed histologic diagnosis are included in the final analysis. Enrollment is conducted on a competitive basis across participating sites, with a target of approximately 50% of enrolled patients having intrahepatic cholangiocarcinoma, given the higher frequency of actionable mutations in this subtype.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Hong Jae Chon, MD. PhD, 82-31-780-3928, hongjaechon@gmail.com
Hong Jae Chon
About this study
Official title: 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.
Read more
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.
Read the 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 first-line therapy with gemcitabine and cisplatin, now combined with immune checkpoint inhibitors, still provides limited long-term survival. Targeted therapies - including FGFR inhibitors for FGFR2 fusions, IDH1 inhibitors, and HER2-directed agents - have improved outcomes in molecularly selected subsets of patients. However, tumor tissue acquisition remains challenging in BTC due to the anatomically inaccessible location of many tumors and frequently insufficient tumor content, limiting the ability to perform comprehensive genomic profiling in a substantial proportion of patients.
Circulating tumor DNA (ctDNA) has emerged as a promising, minimally invasive biomarker for molecular profiling in BTC. While plasma-based ctDNA has shown acceptable concordance with tissue-based next-generation sequencing (NGS) in prior studies, its sensitivity is reduced in patients with locally advanced disease due to lower circulating DNA concentrations. Because bile is in direct contact with biliary tumors, it may harbor tumor-derived DNA at substantially higher concentrations and variant allele frequencies than plasma, suggesting the potential for improved sensitivity and reliability in mutation detection. Preliminary data support higher bile DNA yield and higher concordance with tumor tissue NGS compared with plasma ctDNA, and bile ctDNA alterations have also shown associations with survival outcomes. However, evidence supporting the clinical utility of bile ctDNA remains limited, and no large-scale prospective study has systematically evaluated its concordance with tumor tissue genomic profiling.
This prospective, multicenter, observational study will enroll 100 Korean patients with advanced or metastatic BTC from 4 hospitals, using a competitive enrollment strategy with a target of approximately 50% intrahepatic cholangiocarcinoma. Eligible patients provide a single blood sample (approximately 20 mL) and a single bile sample (approximately 20 mL, collected as residual fluid during clinically indicated biliary drainage via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)) prior to first-line systemic anti-cancer therapy; no additional invasive procedure is performed solely for research purposes. Collected samples are sent to an external laboratory for ctDNA extraction and NGS-based genomic analysis.
The primary objective is to evaluate the concordance of genetic variants between bile ctDNA and tumor tissue DNA in patients with advanced BTC. Secondary objectives include:
- Assessing the frequency of actionable genomic alterations (FGFR2 fusion, IDH1 mutation, HER2 amplification) detected in bile ctDNA
- Evaluating the concordance of genetic variants between bile ctDNA and plasma ctDNA
- Comparing mutation detection rates among bile ctDNA, plasma ctDNA, and tumor tissue DNA Exploratory analyses will examine the association between bile ctDNA maximum variant allele frequency (max VAF) and tumor burden/clinical prognosis, characterize additional genetic variants uniquely detected in bile ctDNA, and explore potential therapeutic targets identified through bile ctDNA-based genomic analysis.
This study is expected to provide evidence for the clinical utility of bile ctDNA as a complementary or alternative molecular diagnostic tool in BTC, particularly for patients in whom tumor tissue acquisition is difficult, and to contribute to the development of precision medicine strategies for patient-tailored treatment selection.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Bile Sampling for ctDNA Analysis
- Keywords
- Biliary Tract Cancer, Biomarker, Circulating Tumor DNA (ctDNA)
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bile Sampling for ctDNA AnalysisOther
Also called Liquid Biopsy; Bile Collection
Bile (approximately 20 mL) is collected once from patients with advanced biliary tract cancer, prior to first-line systemic therapy. The sample is obtained as residual fluid during a clinically indicated biliary drainage procedure (ERCP or PTBD); no additional invasive procedure is performed for research purposes. The sample is sent to an external laboratory for circulating tumor DNA (ctDNA) extraction and next-generation sequencing (NGS)-based genomic analysis, to evaluate concordance of genetic variants with tumor tissue DNA and, where available, plasma ctDNA.
| Study group | Role | What they receive |
|---|---|---|
| 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 bile samples for circulating tumor DNA (ctDNA) analysis before systemic therapy or prior to subsequent treatment. Receives: Other: Bile Sampling for ctDNA Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate of genetic variants between bile ctDNA and tumor tissue DNA
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.
Measured: Baseline
Secondary outcomes (3)
Frequency of actionable genomic alterations detected in bile ctDNA
Frequency of FGFR2 fusion, IDH1 mutation, and HER2 amplification detected by NGS-based analysis of bile-derived ctDNA.
Measured: Up to 24 months
Concordance rate of genetic variants between bile ctDNA and plasma ctDNA
Concordance of genetic variants detected by NGS between bile ctDNA and plasma ctDNA, assessed using sensitivity and positive predictive value where applicable.
Measured: Up to 24 months
Mutation detection rate comparison among bile ctDNA, plasma ctDNA, and tumor tissue DNA
Proportion of genetic variants detected in each of the three sample types (bile ctDNA, plasma ctDNA, tumor tissue DNA), compared across sample sources.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Jae Chon, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830628
- Sponsor's protocol ID
- CHAMC 2026-06-033
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han 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.
PubMed 34572808Gou 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.
PubMed 34653800Li 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.
PubMed 36091112Hwang 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.
PubMed 39442892
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07830628
- Acronym / sponsor ID
- CHAMC 2026-06-033
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- Biliary Tract Cancer, Biomarker, Circulating Tumor DNA (ctDNA)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 first-line therapy with gemcitabine and cisplatin, now combined with immune checkpoint inhibitors, still provides limited long-term survival. Targeted therapies - including FGFR inhibitors for FGFR2 fusions, IDH1 inhibitors, and HER2-directed agents - have improved outcomes in molecularly selected subsets of patients. However, tumor tissue acquisition remains challenging in BTC due to the anatomically inaccessible location of many tumors and frequently insufficient tumor content, limiting the ability to perform comprehensive genomic profiling in a substantial proportion of patients.
Circulating tumor DNA (ctDNA) has emerged as a promising, minimally invasive biomarker for molecular profiling in BTC. While plasma-based ctDNA has shown acceptable concordance with tissue-based next-generation sequencing (NGS) in prior studies, its sensitivity is reduced in patients with locally advanced disease due to lower circulating DNA concentrations. Because bile is in direct contact with biliary tumors, it may harbor tumor-derived DNA at substantially higher concentrations and variant allele frequencies than plasma, suggesting the potential for improved sensitivity and reliability in mutation detection. Preliminary data support higher bile DNA yield and higher concordance with tumor tissue NGS compared with plasma ctDNA, and bile ctDNA alterations have also shown associations with survival outcomes. However, evidence supporting the clinical utility of bile ctDNA remains limited, and no large-scale prospective study has systematically evaluated its concordance with tumor tissue genomic profiling.
This prospective, multicenter, observational study will enroll 100 Korean patients with advanced or metastatic BTC from 4 hospitals, using a competitive enrollment strategy with a target of approximately 50% intrahepatic cholangiocarcinoma. Eligible patients provide a single blood sample (approximately 20 mL) and a single bile sample (approximately 20 mL, collected as residual fluid during clinically indicated biliary drainage via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)) prior to first-line systemic anti-cancer therapy; no additional invasive procedure is performed solely for research purposes. Collected samples are sent to an external laboratory for ctDNA extraction and NGS-based genomic analysis.
The primary objective is to evaluate the concordance of genetic variants between bile ctDNA and tumor tissue DNA in patients with advanced BTC. Secondary objectives include:
- Assessing the frequency of actionable genomic alterations (FGFR2 fusion, IDH1 mutation, HER2 amplification) detected in bile ctDNA
- Evaluating the concordance of genetic variants between bile ctDNA and plasma ctDNA
- Comparing mutation detection rates among bile ctDNA, plasma ctDNA, and tumor tissue DNA Exploratory analyses will examine the association between bile ctDNA maximum variant allele frequency (max VAF) and tumor burden/clinical prognosis, characterize additional genetic variants uniquely detected in bile ctDNA, and explore potential therapeutic targets identified through bile ctDNA-based genomic analysis.
This study is expected to provide evidence for the clinical utility of bile ctDNA as a complementary or alternative molecular diagnostic tool in BTC, particularly for patients in whom tumor tissue acquisition is difficult, and to contribute to the development of precision medicine strategies for patient-tailored treatment selection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Biliary Tract Cancer Patients | – | Other: Bile Sampling for ctDNA AnalysisPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with advanced (unresectable or metastatic) biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, who are treated at 4 tertiary hospitals in South Korea. Eligible patients are those who are about to undergo clinically indicated biliary drainage (ERCP or PTBD) prior to first-line systemic anti-cancer therapy, from whom residual bile can be collected without any additional invasive procedure. Patients may be enrolled at the time of bile collection even before histologic confirmation of biliary tract cancer; however, only patients with subsequently confirmed histologic diagnosis are included in the final analysis. Enrollment is conducted on a competitive basis across participating sites, with a target of approximately 50% of enrolled patients having intrahepatic cholangiocarcinoma, given the higher frequency of actionable mutations in this subtype.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bile Sampling for ctDNA AnalysisAlso: Liquid Biopsy; Bile CollectionBile (approximately 20 mL) is collected once from patients with advanced biliary tract cancer, prior to first-line systemic therapy. The sample is obtained as residual fluid during a clinically indicated biliary drainage procedure (ERCP or PTBD); no additional invasive procedure is performed for research purposes. The sample is sent to an external laboratory for circulating tumor DNA (ctDNA) extraction and next-generation sequencing (NGS)-based genomic analysis, to evaluate concordance of genetic variants with tumor tissue DNA and, where available, plasma ctDNA. | Other | Advanced Biliary Tract Cancer Patients |
Primary outcome
Concordance rate of genetic variants between bile ctDNA and tumor tissue DNA
Time frame: Baseline
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.
3 secondary outcomes
Frequency of actionable genomic alterations detected in bile ctDNA
Time frame: Up to 24 months
Concordance rate of genetic variants between bile ctDNA and plasma ctDNA
Time frame: Up to 24 months
Mutation detection rate comparison among bile ctDNA, plasma ctDNA, and tumor tissue DNA
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 34572808Han 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.
- Background: PubMed 34653800Gou 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.
- Background: PubMed 36091112Li 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.
- Background: PubMed 39442892Hwang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer (BTC), run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Jae Chon, MD. PhD (82-31-780-3928, hongjaechon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate of genetic variants between bile ctDNA and tumor tissue DNA (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07830628, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.