Longitudinal Assessment of Transient Elastography in Cystic Fibrosis

Completed

Conditions studied: Cystic Fibrosis Liver Disease

In brief

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

Key facts

Study ID

NCT03001388

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

141

Starts

2017-03-08

Expected to finish

2023-05-09

Last updated by the study team

2025-04-11

Who can join

Age: 6 and older, up to 26. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Exited from the PUSH Study
• Unable / unwilling to sign consent

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Cincinnati Children's Hospital Medical — Cincinnati, Ohio, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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