The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05036486

Enrollment

480

Registered

2021-09-05

Start date

2021-10-25

Completion date

2030-12-01

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer (BTC)

Keywords

biliary tract cancer, Next-generation sequencing, precision medicine

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.

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.

Interventions

GENETICnext-generation sequencing

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

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

Countries

Taiwan

Contacts

STUDY_CHAIRLi-Tzong Chen, MD

National Health Research Institutes, Taiwan

PRINCIPAL_INVESTIGATORMing-Huang Chen, MD, PhD

Taipei Veterans General Hospital, Taiwan

PRINCIPAL_INVESTIGATORNai-Jung Chiang, MD, PhD