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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-12

Study Completion Date

2020-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cystic fibrosis Patients

Group Type OTHER

miRNAs isolation from blood samples of patients and control

Intervention Type OTHER

Blood sample collection in specific PAXGene tubes

Patients without fibrosis cystic

Group Type OTHER

miRNAs isolation from blood samples of patients and control

Intervention Type OTHER

Blood sample collection in specific PAXGene tubes

Cystic fibrosis Patients (secondary use of samples)

Group Type OTHER

miRNAs isolation from blood samples of patients and control

Intervention Type OTHER

Blood sample collection in specific PAXGene tubes

Interventions

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miRNAs isolation from blood samples of patients and control

Blood sample collection in specific PAXGene tubes

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes