Trials / Completed
CompletedNCT03001388
Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 141 (actual)
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
- Sex
- All
- Age
- 6 Years – 26 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transient Elastography (TE) | Participants enrolled in Cystic Fibrosis Liver Disease Network (CFLD NET)Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH) study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers) |
Timeline
- Start date
- 2017-03-08
- Primary completion
- 2023-05-09
- Completion
- 2023-05-09
- First posted
- 2016-12-23
- Last updated
- 2025-04-11
Locations
8 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT03001388. Inclusion in this directory is not an endorsement.