Prospective Cohort of Patients With Hepatocellular Carcinoma in France
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Variation of overall survival time (OS) after chemoembolization
研究概览
简要总结
Hepatocellular carcinoma (HCC) occurs in 90% of cirrhosis primary liver cancers. In France, 8,500 new cases of HCC occur each year, and about 8,000 deaths per year are related to this cancer. The 5-year survival rate is 10%, one of the lowest survival rates of all cancer types. HCC raises a number of major challenges: HCC is discovered at a curable stage in only 25% of cases, reflecting the marked delay in the diagnosis of early stages. The state of knowledge about HCC is well behind that of other cancers (no biomarker, complex carcinogenesis, influence of the aetiology, poorly valorised data, etc.). Rapid technological progress requires large-scale studies to evaluate new diagnostic and therapeutic modalities.
The CHIEF project constitutes a common basis knowledge for research project using prospectively collected data in patients with HCC, regardless of the cause and stage of the cancer.
This project is a Multicentre longitudinal observational study of patients with HCC with prospective data collection on inclusion and patient follow-up. Constitution of a biological resources collection. 5,000 patients will be included over 2 years with a follow-up of patients of 5 years.
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
- •New cases of HCC
- •suspected case of HCC regardless of the cause, stage, treatment
- •Known HCC: drug treatment for recurrence or progression
排除标准
- •Associated serious condition threatening life in the short term (with the exception of liver disease itself)
- •So-called vulnerable populations: minors, persons under guardianship or temporary guardianship, or person deprived of their liberty by an administrative or judicial decision
结局指标
主要结局
Variation of overall survival time (OS) after chemoembolization
时间窗: from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after chemoembolization
Variation of overall survival time (OS) after radioembolization
时间窗: from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after radioembolization
Variation of progression free survival (PFS) in intent to treat after liver transplantation
时间窗: from day 1 of inclusion, up to 5 years
Variation of progression free survival (PFS) in intent to treat after liver transplantation
Variation of time until failure of the strategy after hepatic resection and percutaneous destruction
时间窗: from day 1 of inclusion, up to 5 years
Variation of time until failure of the strategy after hepatic resection and percutaneous destruction
Variation of overall survival time (OS) after pharmaceutical treatment
时间窗: from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after pharmaceutical treatment
次要结局
- Variation of adverse event rate of HCC treatments in clinical practice(from day 1 of inclusion, up to 5 years)
- Variation of serious adverse event rate of HCC treatments in clinical practice(from day 1 of inclusion, up to 5 years)
