跳至主要内容
临床试验/NCT04348838
NCT04348838招募中不适用

Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年9月26日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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