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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Japan Liver Oncology Group.
Recruitment status was  Recruiting
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

May 21, 2011
May 25, 2011
September 2010
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01360879 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood, serum, liver tissue

Probability Sample

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.

  • Chronic Hepatitis B
  • Chronic Hepatitis C
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
September 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
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
Japan
 
NCT01360879
JLOG1002
Yes
Japan Liver Oncology Group, Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Japan Liver Oncology Group
Not Provided
Study Chair: Masatoshi Kudo, Professor Kinki University Faculty of Medicine
Japan Liver Oncology Group
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP