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NCT03001388 · ClinicalTrials.gov registry record
Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
A clinical trial of Cystic Fibrosis Liver Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 141
- Enrollment target
- 8
- Study locations
NCT03001388: Completed study of Cystic Fibrosis Liver Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT03001388 is a study of Cystic Fibrosis Liver Disease that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 141 participants. The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03001388, a study of Cystic Fibrosis Liver Disease, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 141 participants
- Enrollment target
- 8
- Study locations
Study 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
Primary Outcome
Liver stiffness" quantifies liver fibrosis and is measured in kPa (median of 10 subsequent valid measurements and are deemed acceptable if the ratio of interquartile range and median is \<30% and success rate is \>60%, meaning 10 valid measurements are obtained within 16 attempts).
Conditions Studied
Interventions
- PROCEDURE Transient Elastography (TE)
Study Locations (8)
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Ohio
- Cincinnati Children's Hospital Medical - Cincinnati
Texas
- Texas Children's Hospital - Houston
Washington
- Seattle Children's Hospital - Seattle
Ontario
- The Hospital for Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2023-05-09 |
What the finished NCT03001388 record still lists
NCT03001388 is an observational study that tracks outcomes without assigning an intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Cystic Fibrosis Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Transient Elastography (TE) is the first listed.
NCT03001388 lists 8 locations in 8 states (Colorado, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT03001388 about?
NCT03001388 is a clinical study titled "Longitudinal Assessment of Transient Elastography in Cystic Fibrosis". 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 whethe...
What is the current status of trial NCT03001388?
This trial is currently completed. The enrollment target is 141 participants. The study started on 2017-03-08. Estimated completion is 2023-05-09.
What conditions does trial NCT03001388 study?
This clinical trial studies the following conditions: Cystic Fibrosis Liver Disease.
What interventions are being tested in trial NCT03001388?
The interventions under investigation include: Transient Elastography (TE) (PROCEDURE).
Who is sponsoring clinical trial NCT03001388?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03001388 being conducted?
This trial has 8 study locations across Colorado, Georgia, Illinois, Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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