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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 May 2015
Main ID:  NCT02181452
Date of registration: 19/06/2014
Prospective Registration: No
Primary sponsor: SuperSonic Imagine
Public title: Liver Fibrosis Assessment With ShearWave Elastography
Scientific title: Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases
Date of first enrolment: November 2013
Target sample size: 2333
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02181452
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Retrospective  
Phase:  N/A
Countries of recruitment
Belgium China Denmark France Germany Greece Hong Kong Israel
Italy Romania
Contacts
Name:     Mireen Freidrich-Rust
Address: 
Telephone:
Email:
Affiliation:  Johan Goethe University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients meeting a single condition below:

- Chronic hepatitis B, defined by serology HBsAg positive and the presence of DNA
/ RNA in the serum, or

- Chronic hepatitis C, defined by serology anti-HCV positive and the presence of
DNA / RNA in the serum, or

- non-alcoholic fatty-liver disease

- And meeting all of the conditions below:

- liver biopsy for histological evaluation of liver fibrosis

- Length of liver biopsy = 15 mm paraffin sections (except if cirrhosis)

- Age of majority in their country

- Obtaining the signature of consent for participation in the data collection, in
addition to the routine consent form routinely used at the sites.

Exclusion Criteria:

- Cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune
hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic
fatty-liver disease

- History of antiviral therapy for 6 months or less of current antiviral therapy

- Any systemic, viral hepatitis and HIV co-infection

- Pregnant woman

- Failure to obtain consent

- Length of all liver biopsy specimens below 15mm



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Liver Fibrosis
Intervention(s)
Primary Outcome(s)
Correlation coefficients between factors and liver stiffness [Time Frame: Within one year of the study start date]
Secondary Outcome(s)
Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis [Time Frame: Within one year of the study start date]
Technical success rates depending on factors [Time Frame: Within one year of the study start date]
Diagnostic performance of multivariate models to assess liver fibrosis levels [Time Frame: Within one year of the study start date]
Secondary ID(s)
LE1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Johann Wolfgang Goethe University Hospitals
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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