Comparison of Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis (NCT02342964) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis
France56 participantsStarted 2015-01-08
Plain-language summary
Non-invasive methods of the quantification of fibrosis may help to assess the development of fibrosis at a specific moment of the evolution of the disease, in the order to decide the initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic cirrhosis:
* FibroTest,
* The ultrasound impulse elastography, Fibroscan (FS)
* Ultrasound Elastography by ShearWave (SWE)
* Magnetic resonance elastography (MRE). The purpose of this study is to assess the contribution of these methods in the diagnosis of hepatic fibrosis during the evolution of the cystic fibrosis.
Who can participate
Age range
6 Years – 18 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:
* Children with cystic fibrosis aged 6-18 years. The diagnosis of cystic fibrosis will be based on testing the abnormal sweat (\> 60 mEq / L of chloride sweat) and / or on the presence of two pathogen mutations of CFTR.
* Written consent of parents or holders of parental rights.
* Affiliated or benefiting from a national social insurance
Exclusion Criteria:
* Presence of another disease associated with cystic fibrosis that may be responsible for a chronic hepatic disease such as deficiency of alpha-1antitrypsine ZZ genotype or chronic infection by virus B or C.
* Child grafted
* Actual febrile pulmonary infection that can change the value of Fibrotest
* Important peri-hepatic ascites preventing the elasticity measurements by Fibroscan®
* Severe respiratory insufficient preventing attainment of Magnetic Resonance Imagery
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
1
Measure of hepatic elasticity by Fibro Test
Timeframe: Day 0
2
Measure of hepatic elasticity by the ultrasound impulse elastography, Fibroscan (FS)