Back to resultsSmall Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis (MIRDIAMUCO)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
miRNAs isolation from blood samples of patients and control
Sponsored by
About this trial
This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring Patient with Cystic Fibrosis, Patient without Cystic fibrosis
Eligibility Criteria
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
Sites / Locations
- Montpellier University Hospital
- Necker Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Cystic fibrosis Patients
Patients without fibrosis cystic
Cystic fibrosis Patients (secondary use of samples)
Arm Description
Outcomes
Primary Outcome Measures
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls
Secondary Outcome Measures
Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease
Full Information
NCT ID
NCT02992080
First Posted
September 7, 2016
Last Updated
December 30, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02992080
Brief Title
Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis
Acronym
MIRDIAMUCO
Official Title
Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Patient with Cystic Fibrosis, Patient without Cystic fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cystic fibrosis Patients
Arm Type
Other
Arm Title
Patients without fibrosis cystic
Arm Type
Other
Arm Title
Cystic fibrosis Patients (secondary use of samples)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
miRNAs isolation from blood samples of patients and control
Intervention Description
Blood sample collection in specific PAXGene tubes
Primary Outcome Measure Information:
Title
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
Description
Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls
Time Frame
After blood collection: 2 years
Secondary Outcome Measure Information:
Title
Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
Description
Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease
Time Frame
After blood collection 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline RAYNAL, PharmD, PhD
Organizational Affiliation
Montpellier University Hospital (CHU Montpellier) Montpellier University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis
We'll reach out to this number within 24 hrs