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临床试验/NCT00453869
NCT00453869终止不适用

Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
240
试验地点
1
主要终点
Liver fibrosis evaluation

研究概览

简要总结

The prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and virological status) with FibroScan® as gold standard; to evaluate the feasibility of these different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors, alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.

详细描述

Primary outcome: Screening of clinically significant fibrosis with FibroMeter blood score. Screening for hepatitis B and hepatitis C viruses.

Secondary outcome: Clinically significant fibrosis confirmed with FibroScan®.

The means for this study are a clinical questionnaire, a virological screening, a blood score for liver fibrosis: FibroMeter according to cause of the fibrosis and FibroScan® is referent and independent examination.

The expected results from this study are the knowledge of the prevalence of hepatopathies with hepatic fibrosis will be able to justify, possibly, a screening politic of them. This study will permit to evaluate the feasibility of noninvasive screening of the liver fibrosis in the goal to suppress the liver biopsy in a population having numerous drawbacks.

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
Male
接受健康志愿者

入选标准

  • Person over 18,
  • All new inmates, for less than one month, in Angers jail,
  • To have a written informed consent.

排除标准

  • No consent obtained from person,
  • Detention inferior to one month,
  • Person under 18.

结局指标

主要结局

Liver fibrosis evaluation

时间窗: D0

Evaluation of liver fibrosis with blood tests

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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