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TerminatedNCT00453869SNIFF11Updated Dec 12, 2014

Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

An observational study in Liver Fibrosis, sponsored by University Hospital, Angers. Terminated at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.

Sponsored by University Hospital, Angers · Observational

Why this study was terminated
Few prevalence of liver fibrosis in subjects
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Fibrosis

Keywords

  • Liver fibrosis
  • Hepatitis B virus and C virus
  • FibroMeter
  • FibroScan®
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 240 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • No consent obtained from person,
  • Detention inferior to one month,
  • Person under 18.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (actual)

Interventions

  • Otherliver fibrosis evaluation

    Evaluation of liver fibrosis with blood test

06

What researchers measure

Primary outcomes

  1. Liver fibrosis evaluation

    Evaluation of liver fibrosis with blood tests

    Time frame: D0

07

Study locations

1 site
  • University Hospital Angers
    Angers, 49 933, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00453869
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Mar 29, 2007
Start date
Apr 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Dec 12, 2014

Study contacts

Paul CALES, MD, PhD
principal investigator · UH Angers

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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