<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/NCT03299608</url>
  </required_header>
  <id_info>
    <org_study_id>S60785</org_study_id>
    <nct_id>NCT03299608</nct_id>
  </id_info>
  <brief_title>Rapid Analysis of Infections by Spectrometry of Exhaled Breath</brief_title>
  <acronym>RAISE</acronym>
  <official_title>Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of&#xD;
      exhaled breath from hematological patients with respiratory infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 21, 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>Through study completion (i.e. 6 weeks after diagnosis)</time_frame>
    <description>Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT</measure>
    <time_frame>2 weeks after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT</measure>
    <time_frame>6 weeks after diagnosis</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">246</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <condition>Hematologic Diseases</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath analysis</intervention_name>
    <description>Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at high risk for opportunistic respiratory infections due to acute myeloid or&#xD;
        lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem&#xD;
        cell transplantation, and patients receiving autologous stem cell transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18y at start of study&#xD;
&#xD;
          -  One of the following diagnoses:&#xD;
&#xD;
               -  De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy&#xD;
&#xD;
               -  De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive&#xD;
                  chemotherapy&#xD;
&#xD;
               -  Aplastic anemia requiring ATG therapy&#xD;
&#xD;
               -  Any patient admitted for either autologous hematopoietic stem cell&#xD;
                  transplantation. Transplantation may not have been performed at time of&#xD;
                  enrolment.&#xD;
&#xD;
               -  Any patient admitted with allogeneic hematopoietic stem cell transplantation&#xD;
                  within the last year, or planned during this admission.&#xD;
&#xD;
          -  Written informed consent obtained from the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematological disease beyond the specified inclusion criteria&#xD;
&#xD;
          -  Signs of active respiratory infection&#xD;
&#xD;
          -  If previously enrolled: incomplete clearance of all signs of respiratory infection&#xD;
             (both clinically, microbiologically and radiologically).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Toine Mercier, MD</last_name>
    <phone>+32 16 34 00 04</phone>
    <email>toine.mercier@uzleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toine Mercier, MD</last_name>
      <phone>+32 16 34 00 04</phone>
      <email>toine.mercier@uzleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Hematologic Diseases</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/NCT03299608
org study id: S60785
nct id: NCT03299608
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of
      exhaled breath from hematological patients with respiratory infection.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy
time frame: Through study completion (i.e. 6 weeks after diagnosis)
description: Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy
measure: Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
time frame: 2 weeks after diagnosis
measure: Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
time frame: 6 weeks after diagnosis
intervention type: Diagnostic Test
intervention name: Breath analysis
description: Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Toine Mercier, MD
phone: +32 16 34 00 04
email: toine.mercier@uzleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Hematologic Diseases
sharing ipd: No