<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02992080</url>
  </required_header>
  <id_info>
    <org_study_id>9548</org_study_id>
    <nct_id>NCT02992080</nct_id>
  </id_info>
  <brief_title>Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis</brief_title>
  <acronym>MIRDIAMUCO</acronym>
  <official_title>Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to assess miRNAs expression profiles in the circuling blood of&#xD;
      patients with cystic fibrosis and highlight &quot;signatures&quot; that could reflect the pulmonary&#xD;
      status of patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this project is to study the circulating miRNA profiles in 40 patients with&#xD;
      cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy&#xD;
      individuals to assess whether these biomolecules could be used as markers of the pulmonary&#xD;
      disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic&#xD;
      fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to&#xD;
      assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary&#xD;
      disease. The identification of sensitive and early markers, from a non-invasive sampling&#xD;
      could enable more effective and early treatment of CF patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2016</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls</measure>
    <time_frame>After blood collection: 2 years</time_frame>
    <description>Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status</measure>
    <time_frame>After blood collection 2 years</time_frame>
    <description>Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Cystic fibrosis Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without fibrosis cystic</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cystic fibrosis Patients (secondary use of samples)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>miRNAs isolation from blood samples of patients and control</intervention_name>
    <description>Blood sample collection in specific PAXGene tubes</description>
    <arm_group_label>Cystic fibrosis Patients</arm_group_label>
    <arm_group_label>Cystic fibrosis Patients (secondary use of samples)</arm_group_label>
    <arm_group_label>Patients without fibrosis cystic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Cystic fibrosis (CF) (MIM#219700) who are compound heterozygous or&#xD;
             homozygous for CF causing mutations Healthy controls non -smokers and free pulmonary&#xD;
             disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation or within the exclusion period of other clinicals trials Patients&#xD;
             carrying mutations of clinical varying consequences or non CF-causing mutations&#xD;
&#xD;
          -  smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline RAYNAL, PharmD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montpellier University Hospital (CHU Montpellier) Montpellier University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Necker Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 30, 2021</last_update_submitted>
  <last_update_submitted_qc>December 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient with Cystic Fibrosis</keyword>
  <keyword>Patient without Cystic fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992080
org study id: 9548
nct id: NCT02992080
lead sponsor: 
has dmc: No
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
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
time frame: After blood collection: 2 years
description: Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls
measure: Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status
time frame: After blood collection 2 years
description: Compare the distributions of miRNAs expression in blood samples of CF patients with mild lung disease and CF patients with severe lung disease
arm group label: Cystic fibrosis Patients
arm group type: Other
arm group label: Patients without fibrosis cystic
arm group type: Other
arm group label: Cystic fibrosis Patients (secondary use of samples)
arm group type: Other
intervention type: Other
intervention name: miRNAs isolation from blood samples of patients and control
description: Blood sample collection in specific PAXGene tubes
arm group label: Cystic fibrosis Patients
arm group label: Cystic fibrosis Patients (secondary use of samples)
arm group label: Patients without fibrosis cystic
criteria: 
gender: All
minimum age: 12 Months
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline RAYNAL, PharmD, PhD
role: Principal Investigator
affiliation: Montpellier University Hospital (CHU Montpellier) Montpellier University
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Lung Diseases
mesh term: Fibrosis
sharing ipd: No