NCT00453869

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

March 28, 2007

Last Update Submit

December 11, 2014

Conditions

Liver Fibrosis

Keywords

Liver fibrosisHepatitis B virus and C virusFibroMeterFibroScan®

Outcome Measures

Primary Outcomes (1)

  • Liver fibrosis evaluation

    Evaluation of liver fibrosis with blood tests

    D0

Interventions

liver fibrosis evaluationOTHER

Evaluation of liver fibrosis with blood test

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects in jail who have a medical evaluation.

You may qualify if:

  • Person over 18,
  • All new inmates, for less than one month, in Angers jail,
  • To have a written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Angers

Angers, 49 933, France

Location

MeSH Terms

Conditions

Liver CirrhosisHepatitis B

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Study Officials

  • Paul CALES, MD, PhD

    UH Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

December 12, 2014

Record last verified: 2014-12

Locations

FR(1)