Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
- Conditions
- Cystic Fibrosis Liver Disease
- Registration Number
- NCT03001388
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
-
Participants enrolled in CFLD NET PUSH study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers)
-
Entry criteria for that study were:
-
CF as determined by sweat chloride >60 meq/l
-
Pancreatic insufficiency
-
Age 3-12 years old at entry
-
For entry into the longitudinal follow up subjects were in one of two groups
- A screening US pattern of nodular liver (CIR), heterogeneous increased echogenicity (HTG) or homogeneous increased echogenicity (HMG)
- A screening US pattern of normal (NL) matched to a HTG subject (2 NL:1HTG) by age, center and pseudomonas status
- Exited from the PUSH Study
- Unable / unwilling to sign consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM Year 2 Liver stiffness" quantifies liver fibrosis and is measured in kPa (median of 10 subsequent
- Secondary Outcome Measures
Name Time Method Comparison of liver stiffness and liver steatosis measurements at each time point to clinical findings of portal hypertension Baseline, Year 1 and Year 2 Grayscale ultrasound grades will be obtained from the parent study (PUSH: Clinical Trials: NCT01144507)
Comparison of liver stiffness and liver steatosis measurements at each time point to grayscale ultrasound grades Baseline, Year 1 and Year 2 Grayscale ultrasound grades will be obtained from the parent study (PUSH: Clinical Trials: NCT01144507)
Liver steatosis obtained via transient elastography Baseline, Year 1, Year 2 Controlled Attenuation Parameter (CAP)" quantifies liver steatosis and is measured in dB
Trial Locations
- Locations (8)
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Ann & Robert H. Lurie Children's
🇺🇸Chicago, Illinois, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Cincinnati Children's Hospital Medical
🇺🇸Cincinnati, Ohio, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States