Blood ctDNA testing to find genetic changes in advanced biliary tract cancer
Role of Circulating Tumor DNA (ctDNA) in Genetic Profiling and Clinical Outcomes for Advanced Biliary Tract Cancer (BTC) Patients - A Multicenter, Prospective, Observational Epidemiology Study
CHA University · NCT07142226
This project tests whether a blood test that looks for tumor DNA can reliably find targetable genetic changes in people with advanced biliary tract cancer and help guide treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT07142226 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational study in Korea that uses circulating tumor DNA (ctDNA) next-generation sequencing to profile genomic alterations in patients with advanced or metastatic biliary tract cancer. Eligible patients provide a blood sample either before starting first-line systemic chemotherapy or immediately before a subsequent therapy, and ctDNA results are compared with available tissue-based genomic data and clinical outcomes. The testing panel targets known actionable alterations such as IDH1 mutations, FGFR2 fusions, ERBB2 amplifications, and markers like dMMR/MSI-H. Study goals include measuring concordance with tissue NGS, detecting additional mutations missed by tissue testing, and exploring how ctDNA results relate to treatment decisions and outcomes.
Who should consider this trial
Good fit: Adults (≥19 years) with histologically confirmed advanced or metastatic biliary tract cancer who can provide a blood sample before first-line therapy or immediately before a subsequent systemic treatment are ideal candidates.
Not a fit: Patients who refuse blood sampling, cannot give informed consent, are already enrolled in a similar study at the same center, or have no detectable ctDNA may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, ctDNA testing could make genomic profiling easier and faster, allowing more patients with advanced BTC to be identified for targeted therapies.
How similar studies have performed: Previous studies have shown high concordance between ctDNA and tissue genomic profiling for clinically significant alterations, especially IDH1, and have detected additional mutations not found in tissue.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer). * Patients who meet one of the following conditions: * Patients prior to initiation of first-line systemic chemotherapy, or * Patients previously treated with systemic chemotherapy who can provide a blood sample immediately before starting subsequent therapy. * Age ≥ 19 years at the time of enrollment. * Willingness to provide a blood sample for ctDNA analysis. Exclusion Criteria: * Patients who refuse to provide blood samples for ctDNA testing. * Patients unable to provide written informed consent. * Patients concurrently enrolled in a similar study within the same institution. Prior screening will be performed to prevent duplicate enrollment.
Where this trial is running
Seongnam-si, Gyeonggi-do
- Bundang CHA Medical Center — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
Study contacts
- Principal investigator: Hong Jae Chon, MD. PhD — Principal Investigator
- Study coordinator: Hong Jae Chon, MD. PhD
- Email: minidoctor@cha.ac.kr
- Phone: 82-31-780-3928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biliary Tract Cancer, Biomarker, IDH1 mutation, FGFR2 fusion, Biomarker Analysis, Circulating Tumor DNA