The Prognostic and Predictive Role of Clinical, Biochemical, Pathological and Molecular Characteristics of Patients With Biliary Tract Cancer: an Observational Monocentric Study. (BABEL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.
详细描述
BABEL is an observational, single-center, prospective study with an historical cohort. Study population is represented by patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study involves an historical cohort and a prospective cohort. Primary aim of the study is to associate BTC patients' overall survival with IDH1/2 mutations, in order to confirm the prognostic role of these genes both metastatic and resectable disease setting. The secondary aims are to correlate FGFR mutations and overall survival of BTC patients and to find new clinical and molecular characteristics linked with survival and response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biliary tract cancer;
- •Patients with radiological evident disease;
- •Patients >18 anni;
- •Written informed consent;
- •Patients with at least one oncological visit.
排除标准
- •Patients without available clinical data;
- •Patients without histological diagnosis of BTC;
- •Patients without written informed consent.
结局指标
主要结局
Overall survival
时间窗: The expected OS for BTC patients is 18 months
OS is defined as the time between patient's date of diagnosis and date of death from any cause of the patient. For patients with no observed event, the follow-up time will be ended to the same date.
次要结局
未报告次要终点