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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001388
Other study ID # ELASTIC-CF
Secondary ID U01DK062456
Status Completed
Phase
First received
Last updated
Start date March 8, 2017
Est. completion date May 9, 2023

Study information

Verified date November 2023
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 information / eligibility

Status Completed
Enrollment 141
Est. completion date May 9, 2023
Est. primary completion date May 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 26 Years
Eligibility 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

Study Design


Intervention

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)

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cystic Fibrosis Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Invalid measurements and success rate on liver stiffness and liver steatosis measurements Baseline, Year 1 and Year 2
Other Inter quartile range (IQR) (kPa or dB/m) of all valid measurements within the examination To reflect the dispersion of stiffness and steatosis Baseline, Year 1 and Year 2
Other IQR/median ratio of all valid measurements within the examination This quantity should remain as low as possible to ensure reliable results (goal < 30%) Baseline, Year 1 and Year 2
Primary Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM 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). Baseline
Primary Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM 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). Year 1
Primary Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM Liver stiffness" quantifies liver fibrosis and is measured in kPa (median of 10 subsequent Year 2
Secondary Liver steatosis obtained via transient elastography Controlled Attenuation Parameter (CAP)" quantifies liver steatosis and is measured in dB Baseline, Year 1, Year 2
Secondary Comparison of liver stiffness and liver steatosis measurements at each time point to grayscale ultrasound grades Grayscale ultrasound grades will be obtained from the parent study (PUSH: Clinical Trials: NCT01144507) Baseline, Year 1 and Year 2
Secondary Comparison of liver stiffness and liver steatosis measurements at each time point to clinical findings of portal hypertension Grayscale ultrasound grades will be obtained from the parent study (PUSH: Clinical Trials: NCT01144507) Baseline, Year 1 and Year 2
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04602468 - Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) Phase 4
Not yet recruiting NCT03264950 - Utility of Point Shear-wave Elastography to Assess for Hepatic & Pancreatic Fibrosis in Pediatric CF Patients N/A
Completed NCT03312140 - Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis N/A
Completed NCT03961516 - Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Withdrawn NCT05229640 - Relationship Between the Development of Impaired Glucose Tolerance, the Phenotype of CFLD, and the Risk of Liver Fibrosis N/A
Completed NCT05037643 - Pre-emptive Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Cystic Fibrosis Related Liver Disease N/A
Completed NCT02979340 - MRI to Characterize and Predict CF Liver Disease in PUSH Cohort
Completed NCT04277819 - The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management

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