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

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

Full Title of Study: “Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

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.

Interventions

  • Other: miRNAs isolation from blood samples of patients and control
    • Blood sample collection in specific PAXGene tubes

Arms, Groups and Cohorts

  • Other: Cystic fibrosis Patients
  • Other: Patients without fibrosis cystic
  • Other: Cystic fibrosis Patients (secondary use of samples)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
    • Time Frame: After blood collection 2 years
    • Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Caroline RAYNAL, PharmD, PhD, Principal Investigator, Montpellier University Hospital (CHU Montpellier) Montpellier University

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