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

NCT01360879 | Unknown DMC

• 1 other identifier: JLOG1002
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B; Chronic Hepatitis C

Keywords

Hepatitis B virus; Hepatitis C virus; Chronic hepatitis; Liver cirrhosis; Liver stiffness; Liver fibrosis

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (2)

• Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker

  one year

• Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®

  one year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kindai University: lead

Study Sites (1)

Kinki University Faculty of Medicine

Ōsaka-sayama, Osaka, 589-8511, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, liver tissue

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis C, Chronic; Hepatitis B; Hepatitis C; Hepatitis, Chronic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Flaviviridae Infections; RNA Virus Infections; Fibrosis

Study Officials

• Masatoshi Kudo, Professor

  Kinki University Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Norihisa Yada, M.D.

CONTACT

+81-72-366-0221; yada@med.kindai.ac.jp

Kazuomi Ueshima, M.D.

CONTACT

+81-72-366-0221; kaz-ues@med.kindai.ac.jp

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2011
• First Posted: May 26, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 26, 2011

Record last verified: 2010-08

Locations

JP (1)