Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

NCT ID: NCT00453869

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Fibrosis

Keywords

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Liver fibrosis Hepatitis B virus and C virus FibroMeter FibroScan®

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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liver fibrosis evaluation

Evaluation of liver fibrosis with blood test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No consent obtained from person,
* Detention inferior to one month,
* Person under 18.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul CALES, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

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University Hospital Angers

Angers, , France

Site Status

Countries

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France

Other Identifiers

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DGS 2006-0142 ; CPP 2006/27bis

Identifier Type: -

Identifier Source: secondary_id

PHRC 2006-05

Identifier Type: -

Identifier Source: org_study_id