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Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail (SNIFF11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453869
Recruitment Status : Terminated (Few prevalence of liver fibrosis in subjects)
First Posted : March 29, 2007
Last Update Posted : December 12, 2014
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
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 or disease Intervention/treatment
Liver Fibrosis Other: liver fibrosis evaluation

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail
Study Start Date : April 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Intervention Details:
    Other: liver fibrosis evaluation
    Evaluation of liver fibrosis with blood test

Primary Outcome Measures :
  1. Liver fibrosis evaluation [ Time Frame: D0 ]
    Evaluation of liver fibrosis with blood tests

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects in jail who have a medical evaluation.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00453869

University Hospital Angers
Angers, France, 49 933
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Paul CALES, MD, PhD UH Angers

Responsible Party: University Hospital, Angers Identifier: NCT00453869     History of Changes
Other Study ID Numbers: PHRC 2006-05
DGS 2006-0142 ; CPP 2006/27bis
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Angers:
Liver fibrosis
Hepatitis B virus and C virus

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases