CompletedNot Applicable

Longitudinal Assessment of Transient Elastography in Cystic Fibrosis

United States, Canada141 participantsStarted 2017-03-08

Plain-language 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

Who can participate

Age range

6 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Baseline

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 1

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 2

Trial details

NCT IDNCT03001388

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2023-05-09

View on ClinicalTrials.gov More Cystic Fibrosis Liver Disease trials

Plain-language summary

Who can participate

Age range

6 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Baseline

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 1

Liver Stiffness Measurement (LSM) obtained via transient elastography using FibroScanTM

Timeframe: Year 2