ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer

NCT07151118 | Recruiting

• 1 other identifier: CHAMC2025-03-041
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Cancer

Keywords

Biliary Tract Cancer; Biomarker; IDH1 mutation; FGFR2 fusion; Circulating Tumor DNA (ctDNA); Biomarker Analysis

Outcome Measures

Primary Outcomes (1)

• Detection of Actionable Genomic Alterations by ctDNA Profiling

  Frequency of targetable genetic alterations, especially FGFR2 fusion, detected in ctDNA from patients with advanced biliary tract cancer.

  Baseline (within 30 days prior to initiation of systemic therapy or prior to subsequent treatment)

Secondary Outcomes (2)

• Frequency of Specific Genomic Alterations by ctDNA Analysis

  Up to 24 months

• Proportion of Patients Receiving Targeted Therapy Based on ctDNA Findings

  Up to 24 months

Other Outcomes (5)

• Association of ctDNA Variant Allele Frequency With Clinical Prognosis

  Up to 24 months

• Clinical Outcomes in Patients Treated With Targeted Therapy

  Up to 24 months

• Survival Outcomes in Patients Receiving Targeted Therapy

  Up to 24 months

Study Arms (1)

Advanced Biliary Tract Cancer Patients

Patients with histologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer). Participants will provide blood samples for circulating tumor DNA (ctDNA) analysis before systemic therapy or prior to subsequent treatment.

Other: Blood Sampling for ctDNA Analysis

Interventions

Blood Sampling for ctDNA Analysis OTHER

Approximately 20 mL of peripheral blood will be collected from patients with advanced biliary tract cancer. Samples will be obtained prior to systemic therapy initiation (in about two-thirds of patients) or prior to subsequent therapy (in about one-third of patients). Additional blood draws may be performed at progression in patients with FGFR2 fusion, IDH1 mutation, or HER2 amplification. Collected samples will be centrally analyzed for genomic alterations using ctDNA profiling.

Also known as: Liquid Biopsy; Plasma Collection

Advanced Biliary Tract Cancer Patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean patients with advanced or metastatic biliary tract cancer (intrahepatic, extrahepatic, or gallbladder carcinoma), enrolled for ctDNA-based genetic profiling prior to systemic therapy or before subsequent treatment initiation.

You may qualify if:

• 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

You may not qualify if:

• Refusal to provide blood samples for ctDNA testing
• Inability to provide written informed consent

Sponsors & Collaborators

• CHA University: lead
• Handok Inc.: collaborator

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Related Publications (20)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Blood Specimen Collection; Liquid Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques

Study Officials

• Hong Jae Chon

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jae Chon, MD. PhD

CONTACT

82-31-780-3928; minidoctor@cha.ac.kr

Hong Jae Chon, MD. PhD

CONTACT

82-31-780-3928; hongjaechon@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)