<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/NCT03753828</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2017/34</org_study_id>
    <nct_id>NCT03753828</nct_id>
  </id_info>
  <brief_title>Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.</brief_title>
  <acronym>MucoFong2</acronym>
  <official_title>Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the project &quot;MucoFong&quot; (19021906 national french program n which&#xD;
      Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the&#xD;
      respiratory tract of CF patients responsible for either colonization or authentic infectious&#xD;
      diseases. The Mucofong data allowed the team to provide for the 1st time national French&#xD;
      guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group&#xD;
      coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has&#xD;
      a comprehensive database that it still has to analyze beyond these initial results. The main&#xD;
      goal today is to clarify the role of fungi in the lung function degradation of these patients&#xD;
      by studying the overall risk and estimated impact of fungal colonization in our cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The material includes data from the followup of the 300 patients (3 visits per patient for&#xD;
      which the team collected and verified the biological radiological and clinical data).&#xD;
&#xD;
      Relations between Aspergillus fumigatus or Candida albicans and lung function or clinical&#xD;
      outcome of patients will be longitudinally analyzed taking as output variable FEV1, according&#xD;
      to bibliography data available.&#xD;
&#xD;
      To assess the attributed fungal risk, the team will focus on the 57 patients de novo&#xD;
      colonized by fungi at the second visit. Three physician experts will determine the impact of&#xD;
      such fungal colonization on the patient clinical and respiratory parameters.&#xD;
&#xD;
      The expert conclusion concordance and statistical significance will be evaluated using the&#xD;
      kappa score.&#xD;
&#xD;
      This project will be realized in collaboration with the groups of Prof. R. Thiebaut&#xD;
      (Methodology and Epidemiology Service Bordeaux University Hospital, INSERM U1219 / INRIA&#xD;
      SISTM) and Prof. M. Fayon (Department of Pediatrics, Pediatric reference centre) University&#xD;
      Hospital of Bordeaux.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">October 13, 2018</completion_date>
  <primary_completion_date type="Actual">October 13, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Describe the micromycetes find in lung in patients with cystic fibrosis</measure>
    <time_frame>Day 1</time_frame>
    <description>Relation between the micromycetes and the pathologic lung in patients with cystic fibrosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a. fumigatus, c. albicans or other micromycete</measure>
    <time_frame>Day 1</time_frame>
    <description>Establish the proportion of patients of a colonization in a. fumigatus, in c. albicans or other micromycete, carriers from awareness of a. fumigatus (unlike an ABPA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detect, from data of high-throughput sequencing, combinations of bacteria or fungi are present and clear profile of affinity between genres, in patients with cystic fibrosis.</measure>
    <time_frame>Day 1</time_frame>
    <description>Detect, from data of high-throughput sequencing, combinations of bacteria or fungi are present and clear profile of affinity between genres, in patients with cystic fibrosis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>Cystic Fibrosis Lung</condition>
  <arm_group>
    <arm_group_label>patients de novo colonized by fungi</arm_group_label>
    <description>Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cystic Fibrosis sputum mycological analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        300 patients followed for 2 years including a subpopulation of 40 patients with pro-and&#xD;
        eukaryotic respiratory microbiota documented by high-throughput sequencing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients included in the database meet the following criteria:&#xD;
&#xD;
          -  Patient whose diagnosis of cystic fibrosis has been validated on the criteria in&#xD;
             force,&#xD;
&#xD;
          -  Patient usually followed in one of the 7 centers involved in the PHRC,&#xD;
&#xD;
          -  Patient aged at least 6 years without an upper age limit,&#xD;
&#xD;
          -  Patient benefiting from a mycological assessment carried out in the context of the&#xD;
             usual microbiological monitoring (good clinical practice),&#xD;
&#xD;
          -  Cystic fibrosis Patient benefiting from a mycological assessment carried out in front&#xD;
             of a clinical episode of aggravation requiring biological exploration,&#xD;
&#xD;
          -  Patient who has signed informed consent at the time of inclusion,-patient affiliated&#xD;
             with a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients meeting the following criteria were not included in the database:&#xD;
&#xD;
          -  Pulmonary transplant Patient,&#xD;
&#xD;
          -  Patient or their parents (if the patient is a minor) refusing any participation in the&#xD;
             study,&#xD;
&#xD;
          -  Major incapable subject, under guardianship or under the protection of Justice,&#xD;
&#xD;
          -  Refusal or inability to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurence DELHAES, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital University, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital, Bordeaux</name>
      <address>
        <city>Bourdeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03753828
org study id: CHUBX 2017/34
nct id: NCT03753828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the project "MucoFong" (19021906 national french program n which
      Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the
      respiratory tract of CF patients responsible for either colonization or authentic infectious
      diseases. The Mucofong data allowed the team to provide for the 1st time national French
      guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group
      coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has
      a comprehensive database that it still has to analyze beyond these initial results. The main
      goal today is to clarify the role of fungi in the lung function degradation of these patients
      by studying the overall risk and estimated impact of fungal colonization in our cohort.
The material includes data from the followup of the 300 patients (3 visits per patient for
      which the team collected and verified the biological radiological and clinical data).

      Relations between Aspergillus fumigatus or Candida albicans and lung function or clinical
      outcome of patients will be longitudinally analyzed taking as output variable FEV1, according
      to bibliography data available.

      To assess the attributed fungal risk, the team will focus on the 57 patients de novo
      colonized by fungi at the second visit. Three physician experts will determine the impact of
      such fungal colonization on the patient clinical and respiratory parameters.

      The expert conclusion concordance and statistical significance will be evaluated using the
      kappa score.

      This project will be realized in collaboration with the groups of Prof. R. Thiebaut
      (Methodology and Epidemiology Service Bordeaux University Hospital, INSERM U1219 / INRIA
      SISTM) and Prof. M. Fayon (Department of Pediatrics, Pediatric reference centre) University
      Hospital of Bordeaux.
observational model: Cohort
time perspective: Retrospective
measure: Describe the micromycetes find in lung in patients with cystic fibrosis
time frame: Day 1
description: Relation between the micromycetes and the pathologic lung in patients with cystic fibrosis
measure: Number of patient with a. fumigatus, c. albicans or other micromycete
time frame: Day 1
description: Establish the proportion of patients of a colonization in a. fumigatus, in c. albicans or other micromycete, carriers from awareness of a. fumigatus (unlike an ABPA)
measure: Detect, from data of high-throughput sequencing, combinations of bacteria or fungi are present and clear profile of affinity between genres, in patients with cystic fibrosis.
time frame: Day 1
description: Detect, from data of high-throughput sequencing, combinations of bacteria or fungi are present and clear profile of affinity between genres, in patients with cystic fibrosis
arm group label: patients de novo colonized by fungi
description: Patients in Cystic Fibrosis de novo colonized by fungi during their follow-up
Cystic Fibrosis sputum mycological analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Laurence DELHAES, MD/PhD
role: Principal Investigator
affiliation: Hospital University, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Pulmonary Fibrosis
mesh term: Fibrosis