xml: <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/NCT06037941</url>
    </required_header>
    <id_info>
      <org_study_id>23-100</org_study_id>
      <nct_id>NCT06037941</nct_id>
    </id_info>
    <brief_title>Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma</brief_title>
    <official_title>Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>UNIVERSITY CAMPUS BIO-MEDICO, ITALY</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The researchers are doing this study to test the ability of a new technology called&#xD;
        breathprinting, or electronic nose (E-Nose), to measure how people respond to standard&#xD;
        treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose&#xD;
        breathprints change over time as people receive standard treatment for MPM. They will also&#xD;
        look at how changes in people's E-Nose breathprints compare to changes in their standard&#xD;
        imaging scans and in biomarkers of MPM in their blood.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of MPMspecific VOCs</measure>
      <time_frame>up to 1 year</time_frame>
      <description>compared with imaging (using RECIST 1.1).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Malignant Pleural Mesothelioma</condition>
    <arm_group>
      <arm_group_label>E-Nose Technology</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will undergo E-Nose testing at baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). Patients will undergo E-Nose testing in a presurgical or interventional radiology suite.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>E-Nose testing</intervention_name>
      <description>At baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.</description>
      <arm_group_label>E-Nose Technology</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Research blood</intervention_name>
      <description>Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.</description>
      <arm_group_label>E-Nose Technology</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 30-85 years&#xD;
  &#xD;
            -  No history of thoracic cancer or extrathoracic cancer potentially involving pleural&#xD;
               metastases (i.e., breast, gastric, colon, or pancreas cancer)&#xD;
  &#xD;
            -  Recent diagnosis of MPM&#xD;
  &#xD;
            -  Documented, signed, and dated informed consent, obtained before any procedures, for&#xD;
               the proposed research study, and signed standard surgical consent for surgical&#xD;
               resection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Aged &lt;30 or &gt;85 years at the first outpatient visit&#xD;
  &#xD;
            -  History of thoracic or extrathoracic cancer that puts the subject at risk for pleural&#xD;
               or pulmonary metastases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gaetano Rocco, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gaetano Rocco, MD</last_name>
      <phone>212-639-3478</phone>
      <email>roccog@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Jones, MD</last_name>
      <phone>212-639-6428</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Basking Ridge (Consent Only)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Consent Only)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (Consent Only )</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only)</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (Consent Only)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Consent Only)</name>
        <address>
          <city>Uniondale</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Rocco, MD</last_name>
        <phone>212-639-3478</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Breathprinting (E-Nose) Technology</keyword>
    <keyword>MPM-Specific Volatile Organic Compounds</keyword>
    <keyword>23-100</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mesothelioma</mesh_term>
      <mesh_term>Mesothelioma, Malignant</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037941
  org study id: 23-100
  nct id: NCT06037941
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The researchers are doing this study to test the ability of a new technology called
        breathprinting, or electronic nose (E-Nose), to measure how people respond to standard
        treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose
        breathprints change over time as people receive standard treatment for MPM. They will also
        look at how changes in people's E-Nose breathprints compare to changes in their standard
        imaging scans and in biomarkers of MPM in their blood.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Change of MPMspecific VOCs
  time frame: up to 1 year
  description: compared with imaging (using RECIST 1.1).
  arm group label: E-Nose Technology
  arm group type: Experimental
  description: Patients will undergo E-Nose testing at baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). Patients will undergo E-Nose testing in a presurgical or interventional radiology suite.
  intervention type: Diagnostic Test
  intervention name: E-Nose testing
  description: At baseline (before any treatment is administered) and at three points after treatment (1, 3, and 6 months). A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.
  arm group label: E-Nose Technology
  intervention type: Diagnostic Test
  intervention name: Research blood
  description: Research blood tests will be obtained at baseline, 1, 3, and 6 months post-treatment to determine whether serum biomarkers of MPM.
  arm group label: E-Nose Technology
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Gaetano Rocco, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Gaetano Rocco, MD
  phone: 212-639-3478
  email: roccog@mskcc.org
  last name: David Jones, MD
  phone: 212-639-6428
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Mesothelioma
  mesh term: Mesothelioma, Malignant
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org