Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis (FIBROSTIC)

Tracking Information
First Submitted Date	April 25, 2006
First Posted Date	April 27, 2006
Last Update Posted Date	February 12, 2009
Study Start Date	May 2006
Actual Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00318682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis
Official Title	Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis
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.
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	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA; Description: biological samples to evaluate the hepato-fibrosis
Sampling Method	Non-Probability Sample
Study Population	patient with hepatitis B or C
Condition	Hepatitis, Viral, Human
Intervention	Device: FIBROSCAN; diagnostic examination of the hepato fibrosis
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Terminated
Actual Enrollment; (submitted: February 11, 2009)	2000
Original Enrollment; (submitted: April 25, 2006)	2550
Actual Study Completion Date	August 2008
Actual Primary Completion Date	August 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT00318682
Other Study ID Numbers	IC0504
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mathieu QUINTIN, Department Clinical Research of Developpement
Study Sponsor	Assistance Publique - Hôpitaux de Paris
Collaborators	Not Provided
Investigators	Principal Investigator: Francoise Degos, PhD Hopital Beaujon
PRS Account	Assistance Publique - Hôpitaux de Paris
Verification Date	September 2006