The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
- 试验地点
- 14
- 主要终点
- To perform large-scale NGS analysis for specific populations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
To perform large-scale NGS analysis for specific populations
时间窗: 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
时间窗: 5 years
To enroll 400 patients who fit the criteria of this study in the enrolled period
次要结局
- To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.(5 years)
- Collect clinical data of Biliary tract cancer patients(5 years)