The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

NCT05036486 · tracked via the Priya Life Science China tracker

Sponsor

National Health Research Institutes, Taiwan

Phase

Observational

Started

2021-10-25

Last updated

2026-07-02

Condition(s) studied

Biliary Tract Cancer (BTC)

Investigational drug(s) / intervention(s)

next-generation sequencing

next-generation sequencing: Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis

Study 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.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (13)

Facility	City	Region
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	Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare	Taoyuan	Taiwan

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Other trials for the same condition

A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen Starting soon

Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer. Starting soon

Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer Starting soon

YMN-136 Vaccine for Patients With Advanced Hepatobiliary and Pancreatic Malignancies Recruiting

Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05036486 on ClinicalTrials.gov ↗ ← All trials in China