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| Sponsored by: |
University Hospital, Angers |
| Information provided by: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT00453869 |
Purpose
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.
| Condition |
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Liver Fibrosis |
| MedlinePlus related topics: | Hepatitis Hepatitis B Liver Diseases |
| ChemIDplus related topics: | Hepatitis B Vaccines |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail |
| Estimated Enrollment: | 417 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | June 2008 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paul CALES, MD, PhD | 33 2 41 35 34 10 | paul.cales@univ-angers.fr |
| France | |||||
| University Hospital Angers | Recruiting | ||||
| Angers, France, 49 933 | |||||
| Contact: Pascal VEILLON, PhD 33 2 41 35 49 59 PaVeillon@chu-angers.fr | |||||
| Sub-Investigator: Philippe RICHE, MD | |||||
| Sub-Investigator: Isabelle FOUCHARD-HUBERT, MD | |||||
| University Hospital, Angers |
| Principal Investigator: | Paul CALES, MD, PhD | UH Angers |
More Information
| Study ID Numbers: | PHRC 2006-05, DGS 2006-0142 ; CPP 2006/27bis |
| First Received: | March 28, 2007 |
| Last Updated: | May 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00453869 |
| Health Authority: | France: Direction Général de la Santé – French General Health Administration |
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