NCT02342964

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

November 6, 2014

Last Update Submit

November 17, 2025

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosishepatic fibrosishepatic cirrhosisnon-invasive methods of measurementhepatic elasticity

Outcome Measures

Primary Outcomes (2)

  • Measure of hepatic elasticity by Fibro Test

    The value of hepatic elasticity measured by each of the tests performed on the same day in the same patient

    Day 0

  • Measure of hepatic elasticity by the ultrasound impulse elastography, Fibroscan (FS)

    The value of hepatic elasticity measured by each of the tests performed on the same day in the same patient.

    Month 12

Secondary Outcomes (2)

  • Measure of hepatic elasticity by Ultrasound Elastography by ShearWave (SWE):

    Day 0

  • Measure of hepatic elasticity by Magnetic resonance elastography (MRE):

    Month 12

Study Arms (1)

MUCO-FIBRO

OTHER

Measures of hepatic elasticity

Other: Measure of hepatic elasticity

Interventions

Measure of hepatic elasticityOTHER

Measure of hepatic elasticity by four non-invasive methods: Fibroscan, Fibrotest, SWE, MRE.

MUCO-FIBRO

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker

Paris, 75015, France

Location

Related Publications (1)

  • Dana J, Girard M, Franchi-Abella S, Berteloot L, Benoit-Cherifi M, Imbert-Bismut F, Sermet-Gaudelus I, Debray D. Comparison of Transient Elastography, ShearWave Elastography, Magnetic Resonance Elastography and FibroTest as routine diagnostic markers for assessing liver fibrosis in children with Cystic Fibrosis. Clin Res Hepatol Gastroenterol. 2022 Mar;46(3):101855. doi: 10.1016/j.clinre.2021.101855. Epub 2021 Dec 20.

    PMID: 34933150RESULT

MeSH Terms

Conditions

Cystic FibrosisLiver Cirrhosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesLiver DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dominique Debray, MD, PhD

    00 33 1 44 49 41 52

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

January 21, 2015

Study Start

January 8, 2015

Primary Completion

January 1, 2019

Study Completion

January 24, 2019

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

FR(1)