Skip to content

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

Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992080
Acronym
MIRDIAMUCO
Enrollment
80
Registered
2016-12-14
Start date
2016-07-12
Completion date
2020-06-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Patient with Cystic Fibrosis, Patient without Cystic fibrosis

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.

Interventions

OTHERmiRNAs isolation from blood samples of patients and control

Blood sample collection in specific PAXGene tubes

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 65 Years
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 * smokers

Design outcomes

Primary

MeasureTime frameDescription
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controlsAfter blood collection: 2 yearsCompare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls

Secondary

MeasureTime frameDescription
Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary statusAfter blood collection 2 yearsCompare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCaroline RAYNAL, PharmD, PhD

Montpellier University Hospital (CHU Montpellier) Montpellier University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026