Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease (FIBROELAST)

May 25, 2011 updated by: Japan Liver Oncology Group
This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.

Study Overview

Status

Unknown

Conditions

Detailed Description

The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed.

If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Osaka
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kinki University Faculty of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with chronic hepatitis B or C, undergoing a liver biopsy as the standard of care for their disease, will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.

Description

Inclusion Criteria:

  • Male or female and at least 20 years of age
  • Chronic hepatitis B or Chronic hepatitis C
  • Subject is willing to fast for 8 hours prior to each study visit

Exclusion Criteria:

  • History of alcohol abuse (alcohol intake > 20g/day)
  • Evidence or history of chronic hepatitis not caused by HBV or HCV
  • During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
  • Pregnant or lactating patients
  • Contraindications of liver biopsy or liver resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
Time Frame: one year

To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves.

Sensitivity, specificity and ROC curves obtained under below stiations:

  1. liver fibrosis index diagnose of histological diagnosis F4
  2. liver fibrosis index diagnose of histological diagnosis F3 or greater
  3. liver fibrosis index diagnose of histological diagnosis F2 or greater
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker
Time Frame: one year
To evaluate the correlation between Real-time Tissue Elastography® index and serum markers of hepatic fibrosis, we estimate Pearson correlation coefficient of each request.
one year
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®
Time Frame: one year
To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Liver Oncology Group

Investigators

  • Study Chair: Masatoshi Kudo, Professor, Kinki University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

May 21, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

May 26, 2011

Last Update Submitted That Met QC Criteria

May 25, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLOG1002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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