Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- assessment the prevalence of a broad pool of medical or non-medical (e.g. life-style) conditions among Italian patients with cholangiocarcinoma, in order to evaluate their potential role as a risk factor
研究概览
简要总结
Multi-centric, observational, prospective study, designed for pts with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma.
详细描述
Patients will undergo basal blood sample exams regarding blood cell count, renal and liver function, tumor markers, inflammatory and metabolic state, along with a screening (and, if needed, a more in-depth laboratory analysis) for viral hepatitis infections. Information will be collected about radiological, clinical and pathological features of the neoplasm at time of diagnosis, as well, at a later time, about its natural history. A two-step data analysis will be performed: Task-1 analysis will define the risk factors landscape, Task-2 analysis will examine the influence of etiology on clinical outcomes. Anonymized data will be stored in a central database, kept at the Leading Centre.
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
- •voluntary, written, dated and signed informed consent;
- •age ≥ 18 years;
- •histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.
排除标准
- •Dementia or altered mental status leading to inability to understand or render the informed consent.
- •Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.
结局指标
主要结局
assessment the prevalence of a broad pool of medical or non-medical (e.g. life-style) conditions among Italian patients with cholangiocarcinoma, in order to evaluate their potential role as a risk factor
时间窗: 36 months
次要结局
未报告次要终点