The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
1 other identifier
observational
480
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
January 20, 2026
January 1, 2026
9.1 years
August 9, 2021
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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.
5 years
Interventions
Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis
Eligibility Criteria
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
You may qualify if:
- Ages 20 and above.
- 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.
- Willingness to provide the residual biopsy/operative slides.
- Life expectancy more than 3 months.
- Patients fully understand the protocol with the willingness to have regular follow-up.
- Patients are ready to have 1st systemic treatment or under 1st line therapy
- Total bilirubin ≦5 mg/dL, and ECOG≦2
You may not qualify if:
- Inability to cooperate by providing a complete medical history.
- No available tumor tissues for genetic testing.
- Undesirable compliance.
- Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Memorial Hospitalcollaborator
- Chang Gung Memorial Hospital, Chiayicollaborator
- National Health Research Institutes, Taiwanlead
- National Taiwan University Hospitalcollaborator
- Taipei Veterans General Hospital, Taiwancollaborator
- Tri-Service General Hospitalcollaborator
- Chang Gung Medical Foundation (Linkou Branch)collaborator
- Taipei Medical University Shuang Ho Hospitalcollaborator
- Koo Foundation Sun Yat-Sen Cancer Centercollaborator
- China Medical University Hospitalcollaborator
- National Cheng-Kung University Hospitalcollaborator
- Kaohsiung Medical University Chung-Ho Memorial Hospitalcollaborator
- Taoyuan General Hospital, Ministry of Health and Welfarecollaborator
- Mackay Memorial Hospitalcollaborator
Study Sites (13)
Chang Gung Memorial Hospital, Chiayi
Chiayi City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Linko Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan District, Taiwan
Biospecimen
Oncopanel test
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
September 5, 2021
Study Start
October 25, 2021
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share