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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan® |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Norihisa Yada, M.D. | Contact | +81-72-366-0221 | 3525 | yada@med.kindai.ac.jp |
| Kazuomi Ueshima, M.D. | Contact | +81-72-366-0221 | 3525 | kaz-ues@med.kindai.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Masatoshi Kudo, Professor | Kinki University Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinki University Faculty of Medicine | Recruiting | Ōsaka-sayama | Osaka | 589-8511 | Japan |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D019698 | Hepatitis C, Chronic |
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D006521 | Hepatitis, Chronic |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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whole blood, serum, liver tissue
To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request. |
| one year |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D005355 | Fibrosis |