Blood ctDNA testing to find genetic changes in advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.