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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01360879
Other study ID # JLOG1002
Secondary ID
Status Recruiting
Phase N/A
First received May 21, 2011
Last updated May 25, 2011
Start date September 2010
Est. completion date September 2013

Study information

Verified date August 2010
Source Japan Liver Oncology Group
Contact Norihisa Yada, M.D.
Phone +81-72-366-0221
Email yada@med.kindai.ac.jp
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Locations

Country Name City State
Japan Kinki University Faculty of Medicine Osaka-sayama Osaka

Sponsors (1)

Lead Sponsor Collaborator
Japan Liver Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis 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:
liver fibrosis index diagnose of histological diagnosis F4
liver fibrosis index diagnose of histological diagnosis F3 or greater
liver fibrosis index diagnose of histological diagnosis F2 or greater
one year No
Secondary Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker 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 No
Secondary Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan® To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request. one year No
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