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Clinical Trial Summary

To determine if transient elastography (TE), when combined with ultrasound (US) pattern characterization can improve the prediction of progression to a nodular pattern on US. To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF) To prospectively assess whether TE data are associated with conventional laboratory markers of hepatic fibrosis To determine the variability of TE measurements taken at different sites in the same patient


Clinical Trial Description

A noninvasive assessment of hepatic fibrosis is desperately needed to advance the care of children with CF significant liver disease and to provide for measurements during clinical trials. That global assessment might serve as both a predictor/descriptor of disease course but also as a critical biomarker for clinical research. FibroScan® measurement of liver stiffness has great potential to fill this void. The underlying hypothesis of this proposal is that elastography in addition to US can improved the prediction of the development of a nodular liver on US and development of portal hypertension over time in children and young adults with CF. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03001388
Study type Observational
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status Completed
Phase
Start date March 8, 2017
Completion date May 9, 2023

See also
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Completed NCT03312140 - Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis N/A
Completed NCT03961516 - Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Withdrawn NCT05229640 - Relationship Between the Development of Impaired Glucose Tolerance, the Phenotype of CFLD, and the Risk of Liver Fibrosis N/A
Completed NCT05037643 - Pre-emptive Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Cystic Fibrosis Related Liver Disease N/A
Completed NCT02979340 - MRI to Characterize and Predict CF Liver Disease in PUSH Cohort
Completed NCT04277819 - The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management