NCT00318682

Brief Summary

A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 12, 2009

Status Verified

September 1, 2006

Enrollment Period

2.3 years

First QC Date

April 25, 2006

Last Update Submit

February 11, 2009

Conditions

Hepatitis, Viral, Human

Keywords

biopsyFIBROSCAN

Interventions

FIBROSCANDEVICE

diagnostic examination of the hepato fibrosis

Eligibility Criteria

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

patient with hepatitis B or C

You may qualify if:

  • Chronic hepatitis B or C
  • With liver biopsy indication
  • Patient information

You may not qualify if:

  • Drug hepatitis
  • Metabolic hepatology
  • Steatosis or non-alcoholic steatohepatitis
  • Autoimmune hepatopathy
  • Non-contraindication to liver biopsy
  • Non-contraindication to FIBROSCAN examination
  • Ascites
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

biological samples to evaluate the hepato-fibrosis

MeSH Terms

Conditions

Hepatitis, Viral, Human

Condition Hierarchy (Ancestors)

Virus DiseasesInfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Francoise Degos, PhD

    Hopital Beaujon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 12, 2009

Record last verified: 2006-09

Locations

FR(2)