Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases

NCT01988753 | Completed

• 1 other identifier: H-30472
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Viral Hepatitis; Liver Fibrosis; Liver Disease; Hepatitis B; Hepatitis C

Keywords

Serum Biomarkers; Sheer-wave Elastography; Ultrasound imaging; Viral hepatitis; Liver Fibrosis; Liver disease; Hepatitis B; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Non-invasive shearwave elastography (SWE) for detecting fibrosis in children with liver disease

  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.

  One year

Secondary Outcomes (1)

• Serum Biomarker analysis

  One year

Study Arms (1)

Subjects with Liver Fibrosis

1. Shearwave elastography is a non-invasive procedure for assessing liver status. Measurements of liver tissue elasticity will be obtained in the right lobe of the liver by using a curvilinear transducer (C5-1, Philips Healthcare) through intercostal spaces. 2. 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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children will be recruited from the \>2500 inpatient/outpatient referrals made to the Texas Children's Liver Center per year. 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.

You may qualify if:

• Patients with suspected or established liver disease
• Scheduled to have a clinically indicated liver biopsy
• Between the ages 0-17

You may not qualify if:

• N/A

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. 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. 2. 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.

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases; Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel H Leung, MD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)