CompletedNot Applicable

Longitudinal Assessment of Transient Elastography in Cystic Fibrosis

United States141 participantsStarted 2017-03-08

Plain-language 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

Who can participate

Age range6 Years – 26 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Exited from the PUSH Study * Unable / unwilling to sign consent

What they're measuring

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Baseline

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 1

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 2

Trial details

NCT IDNCT03001388

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

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2023-05-09

View on ClinicalTrials.gov More Cystic Fibrosis Liver Disease trials

Plain-language summary

Who can participate

Age range6 Years – 26 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Baseline

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 1

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 2