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临床试验/NCT00397540
NCT00397540已完成不适用

Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 145 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
2
主要终点
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)

研究概览

简要总结

The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.

详细描述

Prospective cohort study

Survival

  • Overall survival rate
  • Disease free survival rate

Recurrence

  • Cumulative recurrence rate

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Child-Pugh Class A or B
  • Maximal tumor size less than 5 cm
  • No previous history of treatment for hepatocellular carcinoma
  • Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap

排除标准

  • Hepatocellular carcinoma in portal vein
  • Hepatocellular carcinoma in hepatic vein

结局指标

主要结局

1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)

时间窗: 1,3,5 year

The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.

次要结局

  • Overall Survival(through study completion, an average of 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Hwan Yoon

Professor

Seoul National University Hospital

研究点 (2)

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