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

Not Applicable

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT02992080
• Lead Sponsor: University Hospital, Montpellier

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 Timeline

• Study Start: 2016-07-12
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-14
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls	After blood collection: 2 years	Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Montpellier University Hospital; 🇫🇷 Montpellier, France

Necker Hospital; 🇫🇷 Paris, France