<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/NCT02209571</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2014-0076</org_study_id>
    <nct_id>NCT02209571</nct_id>
  </id_info>
  <brief_title>Breath Analysis in in Adults With Cystic Fibrosis (CF)</brief_title>
  <official_title>Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients&#xD;
      with age and gender-matched healthy adults in order to identify a disease-specific exhaled&#xD;
      breath pattern as well as to gain insight into pathophysiological and microbial contributions&#xD;
      to exhaled breath composition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although there is some evidence that breath composition reflects aspects of CF pathology, so&#xD;
      far a disease-specific molecular breath profile has not been identified. Real-time, whole&#xD;
      breath analysis incorporating all of the thousands of potentially relevant volatile compounds&#xD;
      is needed in order to identify reliable CF-specific breath patterns. These may be used in&#xD;
      future clinical applications to greatly enhance cost-effectiveness and simplicity of&#xD;
      diagnostic testing for CF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of clinical records</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Clinical data assessed via questionaire, venous blood markers (clinical routine markers), sputum culture results (clinical routine bacteriology) (results to be reported as a single value for each Arm/Group)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Cystic Fibrosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breath test and venous blood markers in cystic fibrosis patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Breath test and venous blood markers in healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Venous blood markers</intervention_name>
    <description>Routine venous blood sampling</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Cystic Fibrosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of cystic fibrosis (for CF-patients)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous lung transplantation (for CF-patients)&#xD;
&#xD;
          -  Pulmonary exacerbation within the preceding 6 weeks (for CF-patients)&#xD;
&#xD;
          -  Moribund or severe disease prohibiting protocol adherence (for CF-patients)&#xD;
&#xD;
          -  Respiratory illness requiring physician consultation within the preceding 6 weeks (for&#xD;
             controls)&#xD;
&#xD;
          -  Chronic respiratory illness (for controls)&#xD;
&#xD;
          -  Physical or intellectual impairment precluding informed consent or protocol adherence&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malcolm Kohler, MD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Pulmonary Division</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breath Tests</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic 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/NCT02209571
org study id: KEK-ZH-Nr. 2014-0076
nct id: NCT02209571
lead sponsor: 
has dmc: No
Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients
      with age and gender-matched healthy adults in order to identify a disease-specific exhaled
      breath pattern as well as to gain insight into pathophysiological and microbial contributions
      to exhaled breath composition.
Although there is some evidence that breath composition reflects aspects of CF pathology, so
      far a disease-specific molecular breath profile has not been identified. Real-time, whole
      breath analysis incorporating all of the thousands of potentially relevant volatile compounds
      is needed in order to identify reliable CF-specific breath patterns. These may be used in
      future clinical applications to greatly enhance cost-effectiveness and simplicity of
      diagnostic testing for CF.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
time frame: up to 2 years
description: Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)
measure: Composite of clinical records
time frame: up to 2 years
description: Clinical data assessed via questionaire, venous blood markers (clinical routine markers), sputum culture results (clinical routine bacteriology) (results to be reported as a single value for each Arm/Group)
arm group label: Cystic Fibrosis
arm group type: Experimental
description: Breath test and venous blood markers in cystic fibrosis patients
arm group label: Control
arm group type: Active Comparator
description: Breath test and venous blood markers in healthy subjects
intervention type: Other
intervention name: Venous blood markers
description: Routine venous blood sampling
arm group label: Control
arm group label: Cystic Fibrosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Malcolm Kohler, MD, Prof
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis