The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

Study Overview

• Status: Active, not recruiting
• Conditions: Biliary Tract Cancer (BTC)
• Intervention / Treatment: Genetic: next-generation sequencing

Detailed Description

Biliary tract cancer (BTC) compromises a heterogenous group of tumors with poor prognoses. Curative surgery remains the first choice for localized disease; however, most BTC patients had unresectable or metastatic disease. The gold standard therapy for these patients is chemotherapy with gemcitabine and cisplatin. There are no consensus guidelines for standard treatment in a second-line setting, although the data of the ABC-06 trial showed a slight survival benefit from oxaliplatin and 5-fluorouracil combination chemotherapy.

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

• Study Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Chang Gung Memorial Hospital, Chiayi
  • Kaohsiung City, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital,
  • Taichung, Taiwan
    • China Medical University Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taipei, Taiwan
    • Taipei Medical University-Shuang Ho Hospital
  • Taipei, Taiwan
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan District, Taiwan
    • Taoyuan General Hospital, Ministry of Health and Welfare
  • Taoyuan District, Taiwan
    • Linko Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ready to have 1st systemic treatment or under 1st line therapy therapy, metastatic or unresectable population s , clinical information , and therapeutic outcomes in advanced BTC

Description

Inclusion Criteria:

1. Ages 20 and above.
2. Pathological reported showed adenocarcinoma or adenosquamous carcinoma for patients with BTC (include IHCC, EHCC, GBC or AVC) or hepatocholangiocarcinoma as locally advanced or metastatic status.
3. Willingness to provide the residual biopsy/operative slides.
4. Life expectancy more than 3 months.
5. Patients fully understand the protocol with the willingness to have regular follow-up.
6. Patients are ready to have 1st systemic treatment or under 1st line therapy
7. Total bilirubin ≦5 mg/dL, and ECOG≦2

Exclusion Criteria:

1. Inability to cooperate by providing a complete medical history.
2. No available tumor tissues for genetic testing.
3. Undesirable compliance.
4. Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To enroll 400 patients who fit the criteria of this study in the enrolled period	To enroll 400 patients who fit the criteria of this study in the enrolled period	5 years
To perform large-scale NGS analysis for specific populations	To create a map containing important genetic characteristics	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect clinical data of Biliary tract cancer patients	Collect clinical data of Biliary tract cancer patients	5 years
To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.	To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer patients	5 years

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Collaborators: National Taiwan University Hospital; Mackay Memorial Hospital; China Medical University Hospital; Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National Cheng-Kung University Hospital; Taipei Medical University Shuang Ho Hospital; Tri-Service General Hospital; Koo Foundation Sun Yat-Sen Cancer Center; Chang Gung Medical Foundation (Linkou Branch); Chang Gung Memorial Hospital, Chiayi; Taoyuan General Hospital, Ministry of Health and Welfare
• Investigators: Study Chair: Li-Tzong Chen, MD, National Health Research Institutes, Taiwan; Principal Investigator: Ming-Huang Chen, MD, PhD, Taipei Veterans General Hospital, Taiwan; Principal Investigator: Nai-Jung Chiang, MD, PhD, National Health Research Institutes, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: biliary tract cancer; precision medicine; Next-generation sequencing
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Investigative Techniques; Genetic Techniques; Sequence Analysis; High-Throughput Nucleotide Sequencing
• Other Study ID Numbers: T3221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No