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

December 30, 2021 updated by: University Hospital, Montpellier

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital
      • Paris, France, 75015
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After blood collection: 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After blood collection 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Caroline RAYNAL, PharmD, PhD, Montpellier University Hospital (CHU Montpellier) Montpellier University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2016

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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