The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
- Conditions
- Biliary Tract Cancer (BTC)
- Registration Number
- NCT05036486
- Lead Sponsor
- National Health Research Institutes, Taiwan
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 480
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To perform large-scale NGS analysis for specific populations 5 years To create a map containing important genetic characteristics
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
- Secondary Outcome Measures
Name Time Method 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
Collect clinical data of Biliary tract cancer patients 5 years Collect clinical data of Biliary tract cancer patients
Trial Locations
- Locations (13)
Chang Gung Memorial Hospital, Chiayi
🇨🇳Chiayi City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital,
🇨🇳Kaohsiung, 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
Scroll for more (3 remaining)Chang Gung Memorial Hospital, Chiayi🇨🇳Chiayi City, Taiwan