Non-invasive Biomarkers of Fibrosis in Pediatric Viral Hepatitis
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Purpose
This study is being conducted to develop new techniques for early diagnosis of liver disease. These techniques are: Shearwave Elastography (SWE) ultrasound and blood biomarkers.
SWE ultrasound uses high-frequency sound waves to view soft tissues such as muscles and internal organs and measure stiffness. An ultrasound creates computer images that show internal body organs, such as the liver or kidneys, more clearly than regular x-ray images.
Biomarkers are biological molecules found in the blood that provide important information about liver disease.
| Condition |
|---|
|
Viral Hepatitis Liver Fibrosis Liver Disease Hepatitis B Hepatitis C |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Utility of Shearwave Elastography (SWE) and Non-Invasive Serum Biomarkers to Detect Fibrosis in Pediatric Patients With Viral Hepatitis |
- Non-invasive shearwave elastography (SWE) for detecting fibrosis in children with hepatitis [ Time Frame: One year ] [ Designated as safety issue: No ]Philips shearwave ultrasound elastography is a non-invasive procedure for assessing liver status. It provides a virtual biopsy by using liver stiffness data to detect fibrotic changes. It turns an invasive, painful, and expensive procedure into a simple, painless one, making it easier to monitor the 30 patients and leading to a more definitive diagnosis. A commercial US scanner (iU22, Philips Healthcare) was modified to produce shearwaves and track them.
- Serum Biomarker analysis [ Time Frame: One year ] [ Designated as safety issue: No ]Blood will be drawn at the same time the IV is placed for each of the patients the liver biopsy for the purposes of the serum biomarker study. We will study hyaluronic acid, tissue inhibitor of metalloprotease 1, collagen type IV, prolyl hydroxylase and collagen type VI due to previous reports of their biological association with advanced liver disease. Furthermore, we propose to examine the utility of putative serum markers of fibrogenesis in staging hepatic fibrosis and severity of clinical disease in pediatric viral hepatitis.
Biospecimen Retention: Samples Without DNA
- Shearwave elastography is a non-invasive procedure to measurement liver tissue elasticity. Images will be obtained in the right lobe of the liver through intercostal spaces with the subject lying supine with right arm abduction. A total of 10 measurements will be obtained across the liver to obtain a more comprehensive evaluation.
- Biomarker Analysis
A. Blood: Blood will be drawn at the same time the IV is placed for the liver biopsy for the purposes of the serum biomarker study. If subjects return for an additional liver biopsy in the future or a standard of care visit they may be asked to provide an additional sample for biomarker analysis. Blood will be processed, aliquoted and stored by pathology.
B. Tissue: Unstained slides from pathology will be prepared from leftover tissue taken during the liver biopsy to be stained for additional biomarker analysis.
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2013 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
Subjects with Liver Fibrosis
A. Blood: Blood will be drawn at the same time the IV is placed for the liver biopsy for the purposes of the serum biomarker study. If subjects return for an additional liver biopsy in the future or a standard of care visit they may be asked to provide an additional sample for biomarker analysis. Blood will be processed, aliquoted and stored by pathology. B. Tissue: Unstained slides from pathology will be prepared from leftover tissue taken during the liver biopsy to be stained for additional biomarker analysis. |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children will be recruited from the >2500 inpatient/outpatient referrals made to the Texas Children's Liver Center per year, of which over 5% are seen in the Texas Children's Viral Hepatitis Clinic for evaluation, treatment, and management of pediatric HBV or HCV. We will test the utility of putative serum markers of fibrosis and fibrogenesis, obtained from patients for diagnosis and prediction of the likelihood of progression to fibrosis.
Inclusion Criteria:
- Infection with viral hepatitis B or C
- Scheduled to have a clinically indicated liver biopsy
- Between the ages 0-17
Exclusion Criteria:
- N/A
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01988753
| Contact: Jameisha Brown, BS | 832-824-3813 | Jameisha.brown@bcm.edu | |
| Contact: Daniel H Leung, MD | 832-822-3606 | dhleung@texaschildrens.org |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jameisha Brown, BS 832-824-3813 Jameisha.brown@bcm.edu | |
| Principal Investigator: Daniel H Leung, MD | |
| Sub-Investigator: Milton J Finegold, MD | |
| Sub-Investigator: Martha M Munden, MD | |
| Sub-Investigator: Eumenia Castro, MD | |
| Sub-Investigator: Sridevi Devaraj, PhD | |
| Sub-Investigator: Douglas S Fishman, MD | |
| Sub-Investigator: Rajesh Krishnamurthy, MD | |
| Principal Investigator: | Daniel H Leung, MD | Baylor College of Medicine/Texas Children's Hospital |
More Information
No publications provided
| Responsible Party: | Daniel Leung, Assistant Professor, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01988753 History of Changes |
| Other Study ID Numbers: | H-30472 |
| Study First Received: | November 14, 2013 |
| Last Updated: | June 11, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baylor College of Medicine:
|
Serum Biomarkers Sheer-wave Elastography Ultrasound imaging Viral hepatitis |
Liver Fibrosis Liver disease Hepatitis B Hepatitis C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Viral, Human Fibrosis Liver Diseases Digestive System Diseases |
Enterovirus Infections Pathologic Processes Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on March 01, 2015