Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT03001388 |
Recruitment Status :
Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : March 24, 2022
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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
Condition or disease | Intervention/treatment |
---|---|
Cystic Fibrosis Liver Disease | Procedure: Transient Elastography (TE) |
Study Type : | Observational |
Actual Enrollment : | 141 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Longitudinal Assessment of Transient Elastography in Cystic Fibrosis |
Actual Study Start Date : | April 1, 2017 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | June 2023 |

- 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)
- Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM [ Time Frame: Baseline ]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).
- Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM [ Time Frame: Year 1 ]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).
- Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM [ Time Frame: Year 2 ]Liver stiffness" quantifies liver fibrosis and is measured in kPa (median of 10 subsequent
- Liver steatosis obtained via transient elastography [ Time Frame: Baseline, Year 1, Year 2 ]Controlled Attenuation Parameter (CAP)" quantifies liver steatosis and is measured in dB
- Comparison of liver stiffness and liver steatosis measurements at each time point to grayscale ultrasound grades [ Time Frame: Baseline, Year 1 and Year 2 ]Grayscale ultrasound grades will be obtained from the parent study (PUSH: Clinical Trials: NCT01144507)
- Comparison of liver stiffness and liver steatosis measurements at each time point to clinical findings of portal hypertension [ Time Frame: Baseline, Year 1 and Year 2 ]Grayscale ultrasound grades will be obtained from the parent study (PUSH: Clinical Trials: NCT01144507)
- Invalid measurements and success rate on liver stiffness and liver steatosis measurements [ Time Frame: Baseline, Year 1 and Year 2 ]
- Inter quartile range (IQR) (kPa or dB/m) of all valid measurements within the examination [ Time Frame: Baseline, Year 1 and Year 2 ]To reflect the dispersion of stiffness and steatosis
- IQR/median ratio of all valid measurements within the examination [ Time Frame: Baseline, Year 1 and Year 2 ]This quantity should remain as low as possible to ensure reliable results (goal < 30%)

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Ages Eligible for Study: | 6 Years to 26 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001388
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Georgia | |
Children's Healthcare of Atlanta | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Ann & Robert H. Lurie Children's | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Riley Hospital for Children | |
Indianapolis, Indiana, United States, 46202 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical | |
Cincinnati, Ohio, United States, 45229 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Seattle Children's Hospital | |
Seattle, Washington, United States, 98105 | |
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Study Director: | Ed Doo, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |
Study Director: | Averell Sherker, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT03001388 |
Other Study ID Numbers: |
ELASTIC-CF U01DK062456 ( U.S. NIH Grant/Contract ) |
First Posted: | December 23, 2016 Key Record Dates |
Last Update Posted: | March 24, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Cystic Fibrosis Liver Disease Pancreatic insufficiency Cystic Fibrosis Transient Elastography |
Cystic Fibrosis Liver Diseases Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |