Blood-based 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 - Prospective, Observational, Epidemiology Study
This project will test whether a blood test called ctDNA can find actionable genetic changes like FGFR2 fusions and IDH1 mutations in people with advanced or metastatic biliary tract cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Drugs / interventions | pemigatinib |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT07151118 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational study enrolling 100 Korean patients with advanced or metastatic biliary tract cancer across 11 institutions. Blood samples will be collected before first-line or subsequent systemic therapy and analyzed centrally for circulating tumor DNA (ctDNA) to identify alterations such as FGFR2 fusions, IDH1 mutations, and HER2 amplifications. The study will compare ctDNA results with available tissue-based genomic profiling to measure concordance and will perform additional blood draws at progression for patients with selected alterations. Clinical outcomes and prognosis will be correlated with ctDNA findings to determine the clinical relevance of liquid biopsy in this population.
Who should consider this trial
Good fit: Adults (age ≥19) with histologically confirmed advanced or metastatic biliary tract cancer who can provide blood samples before starting first-line or subsequent systemic therapy are ideal candidates.
Not a fit: Patients with early-stage, resectable disease or those who cannot provide blood samples (or who decline consent) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, ctDNA testing could offer a minimally invasive way to detect actionable mutations and help direct targeted treatments for patients with advanced biliary tract cancer.
How similar studies have performed: Prior studies have shown acceptable concordance between ctDNA and tissue sequencing—especially for FGFR2 fusions—and ctDNA has identified alterations missed in tissue, though prospective multicenter data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma) * Patients meeting one of the following conditions: * Prior to initiation of first-line systemic therapy * Patients who previously received systemic therapy and are able to provide a blood sample prior to initiation of subsequent therapy * Age ≥ 19 years at the time of enrollment * Willingness and ability to provide blood samples for ctDNA analysis Exclusion Criteria: * Refusal to provide blood samples for ctDNA testing * Inability to provide written informed consent
Where this trial is running
Seongnam-si, Gyeonggi-do
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Hong Jae Chon — 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.