Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease (FIBROELAST)
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| First Received Date ICMJE | May 21, 2011 | ||||||||
| Last Updated Date | May 25, 2011 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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:
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01360879 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease | ||||||||
| Official Title ICMJE | Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: whole blood, serum, liver tissue |
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| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01360879 | ||||||||
| Other Study ID Numbers ICMJE | JLOG1002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Japan Liver Oncology Group, Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine | ||||||||
| Study Sponsor ICMJE | Japan Liver Oncology Group | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Japan Liver Oncology Group | ||||||||
| Verification Date | August 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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