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

This study has been terminated.
(Few prevalence of liver fibrosis in subjects)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00453869
First received: March 28, 2007
Last updated: December 11, 2014
Last verified: December 2014
  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 Intervention
Liver Fibrosis
Other: liver fibrosis evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Liver fibrosis evaluation [ Time Frame: D0 ] [ Designated as safety issue: No ]
    Evaluation of liver fibrosis with blood tests


Enrollment: 240
Study Start Date: April 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: liver fibrosis evaluation
    Evaluation of liver fibrosis with blood test
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All subjects in jail who have a medical evaluation.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453869

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

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00453869     History of Changes
Other Study ID Numbers: PHRC 2006-05, DGS 2006-0142 ; CPP 2006/27bis
Study First Received: March 28, 2007
Last Updated: December 11, 2014
Health Authority: France: Direction Général de la Santé - French General Health Administration

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

ClinicalTrials.gov processed this record on July 01, 2015