NCT00708617

Brief Summary

Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy. Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using Z test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

July 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

4.8 years

First QC Date

July 1, 2008

Last Update Submit

January 22, 2014

Conditions

Alcoholic Liver Disease

Keywords

Liver fibrosisAlcoholic liver diseaseNon invasive diagnostic methodsTransient elastographyFibrotest

Outcome Measures

Primary Outcomes (1)

  • Patients will be classified according to existence of significant fibrosis (METAVIR score>=2)and cirrhosis (METAVIR score=4) Areas under ROC curve of the diagnostic tests

    up to one week

Secondary Outcomes (1)

  • Diagnostic values of the diagnostic tests will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves.

    up to one week

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Alcoholic Liver Disease

You may qualify if:

  • consecutive excessive drinkers
  • both gender
  • aged 18 to 75 years,
  • hospitalized to manage alcoholic liver disease
  • Ag HBs -, HIV -, HCV -, without any other liver disease than alcohol abuse,
  • with alcohol consumption greater than 80 g per day for at least 5 years
  • with aminotransferase levels anomalies (ASAT ≥ 1.5 N and ALAT \> N) or suspicion of cirrhosis

You may not qualify if:

  • any other liver disease than alcohol abuse,
  • ascitis,
  • contraindication to intercostal liver biopsy
  • IMC\>30
  • liver carcinoma
  • other carcinoma
  • serious associate disease
  • platelets \< 60 GIGAS/L or Quick time \< 50% or TCA \> 1.5 witness time
  • treatment with Plavix® or platelet antiaggregant or anticoagulant
  • intercostal liver biopsy refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AP-HP Hôpital Antoine Beclere

Clamart, 92141, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

AP-HP Hôpital Cochin

Paris, 75005, France

Location

MeSH Terms

Conditions

Liver Diseases, AlcoholicLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvie Naveau, PhD

    Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 2, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

FR(3)