Cystic Fibrosis Liver DiseaseNCT03001388
Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
An observational study of Cystic Fibrosis Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 8 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 6 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis Liver Disease
- What is being tested?
- Transient Elastography (TE)
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 8 Mar 2017to 9 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants enrolled in CFLD NET PUSH study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers) All racial and ethnic groups will be included.
Who may be able to join
- 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
Who cannot join
- Exited from the PUSH Study
- Unable / unwilling to sign consent
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Ann & Robert H. Lurie Children's
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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
Read the 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
- Cystic Fibrosis Liver Disease
- Being tested
- Transient Elastography (TE)
- Keywords
- Cystic Fibrosis Liver Disease, Pancreatic insufficiency, Cystic Fibrosis, Transient Elastography
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient Elastography (TE)Procedure or surgery
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
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).
Measured: Year 1
Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM
Liver stiffness" quantifies liver fibrosis and is measured in kPa (median of 10 subsequent
Measured: Year 2
Secondary outcomes (3)
Liver steatosis obtained via transient elastography
Controlled Attenuation Parameter (CAP)" quantifies liver steatosis and is measured in dB
Measured: Baseline, Year 1, Year 2
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)
Measured: Baseline, Year 1 and Year 2
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)
Measured: Baseline, Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start8 Mar 2017
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Ed Doo, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Averell Sherker, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001388
- Sponsor's protocol ID
- ELASTIC-CF
- Other IDs
- U01DK062456
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2016
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ye W, Leung DH, Molleston JP, Ling SC, Murray KF, Nicholas JL, Huang S, Karmazyn BW, Harned RK, Masand P, Alazraki AL, Navarro OM, Otto RK, Palermo JJ, Towbin AJ, Alonso EM, Karnsakul WW, Jane Schwarzenberg S, Seidel GF, Siegel M, Magee JC, Narkewicz MR, Jay Freeman A. Association Between Transient Elastography and Controlled Attenuated Parameter and Liver Ultrasound in Children With Cystic Fibrosis. Hepatol Commun. 2021 May 13;5(8):1362-1372. doi: 10.1002/hep4.1719. eCollection 2021 Aug.
PubMed 34430781
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03001388
- Acronym / sponsor ID
- ELASTIC-CF
- Conditions
- Cystic Fibrosis Liver Disease
- Keywords
- Cystic Fibrosis Liver Disease, Pancreatic insufficiency, Cystic Fibrosis, Transient Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants enrolled in CFLD NET PUSH study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers) All racial and ethnic groups will be included.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Exited from the PUSH Study
- Unable / unwilling to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
Liver steatosis obtained via transient elastography
Time frame: Baseline, Year 1, Year 2
Comparison of liver stiffness and liver steatosis measurements at each time point to grayscale ultrasound grades
Time frame: Baseline, Year 1 and Year 2
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 34430781Ye W, Leung DH, Molleston JP, Ling SC, Murray KF, Nicholas JL, Huang S, Karmazyn BW, Harned RK, Masand P, Alazraki AL, Navarro OM, Otto RK, Palermo JJ, Towbin AJ, Alonso EM, Karnsakul WW, Jane Schwarzenberg S, Seidel GF, Siegel M, Magee JC, Narkewicz MR, Jay Freeman A. Association Between Transient Elastography and Controlled Attenuated Parameter and Liver Ultrasound in Children With Cystic Fibrosis. Hepatol Commun. 2021 May 13;5(8):1362-1372. doi: 10.1002/hep4.1719. eCollection 2021 Aug.
- ChiLDReN WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Doo, MD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Averell Sherker, MD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03001388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.