The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Conditions
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Biliary Tract Cancer (BTC)

Intervention / Treatment
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* Genetic: next-generation sequencing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: next-generation sequencing|Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect clinical data of Biliary tract cancer patients | 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. | To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer patients | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliary tract cancer, Next-generation sequencing, precision medicine