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

This study is currently recruiting participants.
Verified August 2010 by Japan Liver Oncology Group
Sponsor:
Information provided by:
Japan Liver Oncology Group
ClinicalTrials.gov Identifier:
NCT01360879
First received: May 21, 2011
Last updated: May 25, 2011
Last verified: August 2010
History of Changes
  Purpose

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.


Condition
Chronic Hepatitis B
Chronic Hepatitis C

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Japan Liver Oncology Group:

Primary Outcome Measures:
  • Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker [ Time Frame: one year ] [ Designated as safety issue: No ]
    To evaluate the correlation between Real-time Tissue Elastography® index and serum markers of hepatic fibrosis, we estimate Pearson correlation coefficient of each request.

  • Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan® [ Time Frame: one year ] [ Designated as safety issue: No ]
    To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request.


Biospecimen Retention:   Samples Without DNA

whole blood, serum, liver tissue


Estimated Enrollment: 500
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360879

Contacts
Contact: Norihisa Yada, M.D. +81-72-366-0221 ext 3525 yada@med.kindai.ac.jp
Contact: Kazuomi Ueshima, M.D. +81-72-366-0221 ext 3525 kaz-ues@med.kindai.ac.jp

Locations
Japan
Kinki University Faculty of Medicine Recruiting
Osaka-sayama, Osaka, Japan, 589-8511
Contact: Norihisa Yada, MD     +81-72-366-0221 ext 3525     yada@med.kindai.ac.jp    
Contact: Kazuomi Ueshima, MD     +81-72-366-0221 ext 3525     kaz-ues@med.kindi.ac.jp    
Sponsors and Collaborators
Japan Liver Oncology Group
Investigators
Study Chair: Masatoshi Kudo, Professor Kinki University Faculty of Medicine
  More Information

No publications provided

Responsible Party: Japan Liver Oncology Group, Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01360879     History of Changes
Other Study ID Numbers: JLOG1002
Study First Received: May 21, 2011
Last Updated: May 25, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Liver Oncology Group:
Hepatitis B virus
Hepatitis C virus
Chronic hepatitis
 Liver cirrhosis
Liver stiffness
Liver fibrosis

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Liver Cirrhosis
Hepatitis B, Chronic
Hepatitis C, Chronic
 Pathologic Processes
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 17, 2013