The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

November 7, 2023 updated by: National Health Research Institutes, Taiwan
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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Chiayi City, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital, Chiayi
        • Contact:
          • Din-yau Wang, M.D.
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
          • Tai-Jan Chiu, MD
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital,
        • Contact:
          • Li-Tzong Chen, MD
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Li-yuan Bai
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Chia-Jui Yen, MD,PhD
      • Taipei, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
          • Jiunn-Chang Lin, M.D.
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Ming-Huang Chen, MD,PhD
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Chiun Hsu, MD,PhD
      • Taipei, Taiwan
        • Recruiting
        • TRI-Service General Hospital
        • Contact:
          • Ming-Shen Dai, MD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:
          • Yao-Yu Hsieh, MD
      • Taipei, Taiwan
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
        • Contact:
          • Hsiao-Hsiang Cheng, MD
      • Taoyuan, Taiwan
        • Recruiting
        • Linko Chang Gung Memorial Hospital
        • Contact:
          • Jen-Shi Chen, MD,PhD
      • Taoyuan, Taiwan
        • Recruiting
        • Taoyuan General Hospital, Ministry of Health and Welfare
        • Contact:
          • Yuan-Hao Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

treatment naïve or under 1 st line 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 5 years
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.
Time Frame: 5 years
To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer patients
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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