NCT07151118Recruiting
ctDNA in Genetic Profiling and Clinical Outcomes of 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
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea. Tissue-based genomic profiling is often limited due to the anatomical challenges of tumor biopsy and insufficient DNA quality. ctDNA analysis offers a minimally invasive alternative for identifying actionable genetic alterations, including Fibroblast Growth Factor Receptor 2 (FGFR2) fusions, Isocitrate Dehydrogenase 1 (IDH1) mutations, and Human Epidermal Growth Factor Receptor 2 (HER2) amplifications. The study will recruit 100 patients across 11 institutions and assess the concordance between ctDNA and tissue genomic profiling, as well as the clinical relevance of ctDNA in predicting treatment outcomes and prognosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- CHA University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07151118
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Sept 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Refusal to provide blood samples for ctDNA testing
- Inability to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.