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/NCT06033248</url>
    </required_header>
    <id_info>
      <org_study_id>23-111</org_study_id>
      <nct_id>NCT06033248</nct_id>
    </id_info>
    <brief_title>Using Urine Samples to Identify Lung Cancer</brief_title>
    <official_title>Validation and Determination of Feasibility for Clinical Use of an Animal Biosensor Platform to Detect Non-Small Cell Lung Cancer-Specific Volatile Organic Compounds in Urine Samples</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>EARLY Labs</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 an animal biosensor platform&#xD;
        (ABP) to detect NSCLC. Participants in this study will either be diagnosed with NSCLC,&#xD;
        suspected to have NSCLC, or have not been diagnosed or suspected to have NSCLC.&#xD;
  &#xD;
        The ABP test uses laboratory animals that are trained to detect (by smell) different&#xD;
        chemicals in urine. Studies show that people with lung cancer have unique chemicals in their&#xD;
        urine that are not present in people without lung cancer, and researchers think these&#xD;
        chemicals can be used to identify people with lung cancer without the need for invasive&#xD;
        procedures (like biopsy).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>detect the presence or absence of NSCLC-specific VOCs</measure>
      <time_frame>2 years</time_frame>
      <description>in urine samples</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Non Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>patients diagnosed with NSCLC</arm_group_label>
      <description>In phase I, the researchers will assess the ability of a rat-based ABP to detect the presence or absence of NSCLC-specific VOCs in urine samples from subjects with and without NSCLC. In phase II, the researchers will assess the ability of the ABP to detect the presence of NSCLC-specific VOCs in urine samples from subjects with suspected but undiagnosed NSCLC (clinical stage I to IIIA). Urine samples will be collected from 50 patients diagnosed with NSCLC and from 50 subjects without NSCLC for phase I and from 110 patients with suspected but undiagnosed NSCLC for phase II (total number of subjects = 210).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>urine sample</intervention_name>
      <description>urine sample will be collected</description>
      <arm_group_label>patients diagnosed with NSCLC</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Thoracic Surgery clinics&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Phase I (with NSCLC): Aged 18 to 90 years with histologically proven, previously&#xD;
               untreated stage I, II, or IIIA NSCLC&#xD;
  &#xD;
            -  Phase I (without NSCLC): Aged 18 to 90 years with patient confirmed absence of NSCLC&#xD;
  &#xD;
            -  Phase II: Aged 18 to 90 years with suspected but undiagnosed stage I, II, or IIIA&#xD;
               NSCLC by CT and/or PET scan criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Aged &lt;18 years&#xD;
  &#xD;
            -  Lack of available results from low-dose CT&#xD;
  &#xD;
            -  Receipt of radiation, chemotherapy, biological therapy, resection, or any other&#xD;
               treatment for any cancer in the previous year&#xD;
  &#xD;
            -  Pregnant (for women)&#xD;
  &#xD;
            -  Taking drugs that affect the immune system&#xD;
  &#xD;
            -  Chronic disease related to the immune system&#xD;
  &#xD;
            -  Missing clinical data (i.e., current clinical staging)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</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 (All Protocol Activities)</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 (All Protocol Activities)</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 (All Protocol Activities)</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 Suffolk-Commack (All Protocol Activities)</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 (All Protocol Activities)</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 (All Protocol Activities)</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 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Urine samples</keyword>
    <keyword>stages I, II, and IIIA</keyword>
    <keyword>23-111</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT06033248
  org study id: 23-111
  nct id: NCT06033248
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The researchers are doing this study to test the ability of an animal biosensor platform
        (ABP) to detect NSCLC. Participants in this study will either be diagnosed with NSCLC,
        suspected to have NSCLC, or have not been diagnosed or suspected to have NSCLC.
  
        The ABP test uses laboratory animals that are trained to detect (by smell) different
        chemicals in urine. Studies show that people with lung cancer have unique chemicals in their
        urine that are not present in people without lung cancer, and researchers think these
        chemicals can be used to identify people with lung cancer without the need for invasive
        procedures (like biopsy).
  observational model: Case-Control
  time perspective: Prospective
  measure: detect the presence or absence of NSCLC-specific VOCs
  time frame: 2 years
  description: in urine samples
  arm group label: patients diagnosed with NSCLC
  description: In phase I, the researchers will assess the ability of a rat-based ABP to detect the presence or absence of NSCLC-specific VOCs in urine samples from subjects with and without NSCLC. In phase II, the researchers will assess the ability of the ABP to detect the presence of NSCLC-specific VOCs in urine samples from subjects with suspected but undiagnosed NSCLC (clinical stage I to IIIA). Urine samples will be collected from 50 patients diagnosed with NSCLC and from 50 subjects without NSCLC for phase I and from 110 patients with suspected but undiagnosed NSCLC for phase II (total number of subjects = 210).
  intervention type: Diagnostic Test
  intervention name: urine sample
  description: urine sample will be collected
  arm group label: patients diagnosed with NSCLC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  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: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  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.