Blood-based 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.