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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992080
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: miRNAs isolation from blood samples of patients and control Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Cystic fibrosis Patients Other: miRNAs isolation from blood samples of patients and control
Blood sample collection in specific PAXGene tubes
Patients without fibrosis cystic Other: miRNAs isolation from blood samples of patients and control
Blood sample collection in specific PAXGene tubes
Cystic fibrosis Patients (secondary use of samples) Other: miRNAs isolation from blood samples of patients and control
Blood sample collection in specific PAXGene tubes


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992080


Locations
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France
Montpellier University Hospital
Montpellier, France, 34295
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Caroline RAYNAL, PharmD, PhD Montpellier University Hospital (CHU Montpellier) Montpellier University
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02992080    
Other Study ID Numbers: 9548
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
Patient with Cystic Fibrosis
Patient without Cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Lung Diseases
Fibrosis
Pathologic Processes
Pancreatic Diseases
 Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases