NCT02181452

Brief Summary

Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver. This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
2,333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
9 countries

13 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

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

June 19, 2014

Last Update Submit

May 11, 2015

Conditions

Liver Fibrosis

Keywords

liverfibrosisShearWave Elastographyultrasound

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficients between factors and liver stiffness

    Factors include patient's clinical and biological parameters

    Within one year of the study start date

Secondary Outcomes (3)

  • Technical success rates depending on factors

    Within one year of the study start date

  • Diagnostic performance of multivariate models to assess liver fibrosis levels

    Within one year of the study start date

  • Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis

    Within one year of the study start date

Eligibility Criteria

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

Population will consist of patients who have confirmed or suspected liver fibrosis and will be assessed with ultrasound, +/- blood analysis, +/- other non-invasive imaging, and/or measurements, and biopsy

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Antwerp

Edegem, Belgium

Location

3rd Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Odense University Hospital

Odense, Denmark

Location

University Hospital of Bordeaux

Bordeaux, France

Location

Beaujon Hospital

Clichy, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Cochin Hospital

Paris, France

Location

University of Bonn

Bonn, Germany

Location

Johan Goethe Universitat

Frankfurt, Germany

Location

University of Athens Medical School

Athens, Greece

Location

Chinese University of Hong Kong - Prince of Wales Hospital

Hong Kong, Hong Kong

Location

University of Pavia

Pavia, Italy

Location

University of Timosoara

Timișoara, Romania

Location

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mireen Freidrich-Rust

    Johan Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2014

First Posted

July 4, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

IT(1)GR(1)CN(1)DE(2)BE(1)HK(1)DK(1)FR(4)RO(1)