Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

Liver Fibrosis Clinical Trial

— SNIFF11  

Official title:

Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00453869
• Other study ID #: PHRC 2006-05
• Secondary ID: DGS 2006-0142
• Status: Terminated
• Phase: N/A
• First received: March 28, 2007
• Last updated: December 11, 2014
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: December 2014
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Général de la Santé - French General Health Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Fibrosis

Intervention

Other:
• liver fibrosis evaluation
Evaluation of liver fibrosis with blood test

Locations

Country	Name	City	State
France	University Hospital Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fibrosis evaluation	Evaluation of liver fibrosis with blood tests	D0	No