- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318682
Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis (FIBROSTIC)
Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis
Study Overview
Detailed Description
The gold standard for the evaluation of fibrosis is considered as the METAVIR score by the clinicians. The results of this score are currently used for clinical decisions and description of the evolution of the disease. FIBROSCAN would be interesting in avoiding liver biopsies, if it was able to predict accurately the METAVIR score obtained if a liver biopsy was performed. The data available on diagnostic performances of FIBROSCAN are incomplete, the number of patients studied and the methods selection (blindness of the results of other techniques) are not precise in some of them. The main objective of this study is therefore to evaluate the performance of FIBROSCAN in the prediction of METAVIR score > 2 (vs F0 or F1). An ancillary study will try to evaluate the diagnostic performance of FIBROSCAN in the global prediction of METAVIR score. A statistical method will be tested using the reference method as an ordinal polytropic variable. Half of the sample (1250 patients) will be used to determine the best THERSHOLD of FIBROSCAN in each of the clinical subgroups of patients, in order to obtain a high sensibility. The second half will be used as the validation sample, and the threshold will be used to estimate the sensibility, specificity and other diagnostic parameters of the FIBROSCAN. The secondary objectives are:
- to evaluate the performance of FIBROSCAN in the prediction of METAVIR score in adjacent classes of fibrosis (F0-F1, F1-F2, F2-F3, F3-F4), and
- to study the association between elastometry and fibrosis surface obtained by morphometry (considered as the best evaluation of global liver fibrosis).
This technique will be applied to a restricted number of biopsies (consecutive biopsies > 2cm).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Clichy, France, 92110
- Hopital Beaujon
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Paris, France, 75012
- Hopital Saint-Antoine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic hepatitis B or C
- With liver biopsy indication
- Patient information
Exclusion Criteria:
- Drug hepatitis
- Metabolic hepatology
- Steatosis or non-alcoholic steatohepatitis
- Autoimmune hepatopathy
- Non-contraindication to liver biopsy
- Non-contraindication to FIBROSCAN examination
- Ascites
- Obesity
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Investigators
- Principal Investigator: Francoise Degos, PhD, Hopital Beaujon
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC0504
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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