Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis

N/ACompletedNCT02992080

University Hospital, Montpellier80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

miRNAs isolation from blood samples of patients and controlOTHER

Blood sample collection in specific PAXGene tubes

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * smokers

Locations (2)

Montpellier University Hospital

Montpellier, France

Necker Hospital

Paris, France

Outcomes

Primary Outcomes

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

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

Time frame: After blood collection: 2 years

Secondary Outcomes

Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status

Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease

Time frame: After blood collection 2 years

Data from ClinicalTrials.gov

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