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NCT Number: NCT05036486

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Biliary Tract Cancer (BTC) Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital, Chiayi, Chiayi City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

next-generation sequencing

Genetic

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

Primary outcomes

  1. 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

  2. To perform large-scale NGS analysis for specific populations

    Time frame: 5 years

    To create a map containing important genetic characteristics

Secondary outcomes

  1. Collect clinical data of Biliary tract cancer patients

    Time frame: 5 years

    Collect clinical data of Biliary tract cancer patients

  2. 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

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • Chang Gung Medical Foundation (Linkou Branch)
  • Chang Gung Memorial Hospital
  • Chang Gung Memorial Hospital, Chiayi
  • China Medical University Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Koo Foundation Sun Yat-Sen Cancer Center
  • Mackay Memorial Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Medical University Shuang Ho Hospital
  • Taipei Veterans General Hospital, Taiwan
  • Taoyuan General Hospital, Ministry of Health and Welfare
  • Tri-Service General Hospital (TSGH)

Registry information

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Sep 5, 2021
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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