Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Patients without fibrosis cystic
Intervention: miRNAs isolation from blood samples of patients and control (Other)
Cystic fibrosis Patients (secondary use of samples)
Intervention: miRNAs isolation from blood samples of patients and control (Other)
Cystic fibrosis Patients
Intervention: miRNAs isolation from blood samples of patients and control (Other)
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)