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Clinical Trials/NCT02992080
NCT02992080
Completed
Not Applicable

Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis

University Hospital, Montpellier2 sites in 1 country80 target enrollmentJuly 12, 2016
ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
University Hospital, Montpellier
Enrollment
80
Locations
2
Primary Endpoint
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients

Detailed Description

The objective of this project is to study the circulating miRNA profiles in 40 patients with cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy individuals to assess whether these biomolecules could be used as markers of the pulmonary disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary disease. The identification of sensitive and early markers, from a non-invasive sampling could enable more effective and early treatment of CF patients.

Registry
clinicaltrials.gov
Start Date
July 12, 2016
End Date
June 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with Cystic fibrosis (CF) (MIM#219700) who are compound heterozygous or homozygous for CF causing mutations Healthy controls non -smokers and free pulmonary disease

Exclusion Criteria

  • Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations

Outcomes

Primary Outcomes

Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls

Time Frame: After blood collection: 2 years

Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls

Secondary Outcomes

  • Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status(After blood collection 2 years)

Study Sites (2)

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