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/NCT06034730</url>
    </required_header>
    <id_info>
      <org_study_id>665139</org_study_id>
      <nct_id>NCT06034730</nct_id>
    </id_info>
    <brief_title>Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer?</brief_title>
    <official_title>Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer? An Exploratory Study on a Cohort of 60 Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Humanitas Hospital, Italy</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari</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>
        Breath analysis examining specific patterns of volatile organic compounds (VOCs) has been&#xD;
        demonstrated to be able to discriminate lung cancer (LC) patients from healthy controls (HC).&#xD;
        However, the existing technology uses complex, expensive, and low throughput analytical&#xD;
        platforms to give an offline response, thus preventing its applicability for mass screening.&#xD;
        The reliability of a new portable device to enable rapid, on-site LC diagnosis is tested.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The breath of patients with histologically proven NSCLC and healthy controls was sampled into&#xD;
        Tedlar bags through a Nafion filter and a one-way mouthpiece. The breath samples in the bags&#xD;
        were then analyzed by an automated micro portable gas chromatography device developed&#xD;
        in-house, which consisted of a thermal desorption tube, thermal injector, separation column,&#xD;
        and photoionization detector, as well as other accessories such as pumps, valves, and a&#xD;
        helium cartridge. The chromatograms were analyzed by chemometrics and machine learning&#xD;
        techniques.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2021</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">September 1, 2022</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>Changes in VOCs peaks in patients with lung cancer vs healthy patients</measure>
      <time_frame>24 hours</time_frame>
      <description>Identify biomarkers able to discriminate between lung cancer patients and healthy controls.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">60</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Lung Cancer Patients</arm_group_label>
      <description>patients undergoing surgery for histologically proven NSCLC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Control Patients</arm_group_label>
      <description>patients undergoing surgery for benign extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative during preoperative evaluation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Portable GC device for brath analysis</intervention_name>
      <description>Patients were asked to orally exhale 1-2 L breath into a 5 L Tedlar bag via a one-way mouthpiece and Nafion filter for moisture removal, as shown in Figure 1B. The process usually takes about a few minutes. The breath analysis took place either in-situ immediately after the breath sample collection or within 24 h of breath collection. The Tedlar bags were stored under ambient condition until analyzed. During the breath analysis, the Tedlar bag was connected to the sampling port of the portable GC (Figure 1C). Approximately 350 mL of breath was pulled from the Tedlar bag into the GC for analysis. The GC operation was controlled using LabView via a laptop. The total assay time was 30 min, including 5 min of breath sampling time from the Tedlar bag at a flow rate of 70 mL/min (see the blue path in Figure 1A), 5 min of desorption/transfer time, 10 min of chromatographic separation time (see the orange path in Figure 1A), and 10 min of GC system cleaning time.</description>
      <arm_group_label>Healthy Control Patients</arm_group_label>
      <arm_group_label>Lung Cancer Patients</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Breath from the patients, retained for a maximum of 24h&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          A total of 60 patients undergoing surgery for histologically proven NSCLC and a comparative&#xD;
          group of non-cancer controls who had negative findings on preoperative chest X-rays/chest&#xD;
          CT scan were admitted to our Thoracic Surgery Unit between August 2021 and March 2022.&#xD;
          Patients underwent breath collection during the pre-hospitalization analysis before&#xD;
          surgery. The control group was recruited from patients undergoing surgery for benign&#xD;
          extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative&#xD;
          during preoperative evaluation.&#xD;
  &#xD;
          Patients excluded from analysis were those who had any history of another type of cancer&#xD;
          and those who had received neoadjuvant chemo/radiotherapy because of the possible unknown&#xD;
          effects on cancer metabolism.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  NSCLC histologically proven (for LC group) at any stage of disease&#xD;
  &#xD;
            -  non-cancer controls who had negative findings on preoperative chest X-rays/chest CT&#xD;
               scan (for HC groups)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had any history of another type of cancer&#xD;
  &#xD;
            -  who had received neoadjuvant chemo/radiotherapy because of the possible unknown&#xD;
               effects on cancer metabolism&#xD;
  &#xD;
            -  pediatric patients.&#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_official>
      <last_name>Giuseppe Marulli, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Humanitas Research Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Azienda Consorziale Ospedaliero-Universitaria Policlinico di Bari - Thoracic Surgery Unit</name>
        <address>
          <city>Bari</city>
          <zip>70121</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 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>breathomic</keyword>
    <keyword>NSCLC</keyword>
    <keyword>screening</keyword>
    <keyword>volatile organic compounds</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>On request alla data will be available</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/NCT06034730
  org study id: 665139
  nct id: NCT06034730
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Breath analysis examining specific patterns of volatile organic compounds (VOCs) has been
        demonstrated to be able to discriminate lung cancer (LC) patients from healthy controls (HC).
        However, the existing technology uses complex, expensive, and low throughput analytical
        platforms to give an offline response, thus preventing its applicability for mass screening.
        The reliability of a new portable device to enable rapid, on-site LC diagnosis is tested.
  The breath of patients with histologically proven NSCLC and healthy controls was sampled into
        Tedlar bags through a Nafion filter and a one-way mouthpiece. The breath samples in the bags
        were then analyzed by an automated micro portable gas chromatography device developed
        in-house, which consisted of a thermal desorption tube, thermal injector, separation column,
        and photoionization detector, as well as other accessories such as pumps, valves, and a
        helium cartridge. The chromatograms were analyzed by chemometrics and machine learning
        techniques.
  observational model: Case-Control
  time perspective: Prospective
  measure: Changes in VOCs peaks in patients with lung cancer vs healthy patients
  time frame: 24 hours
  description: Identify biomarkers able to discriminate between lung cancer patients and healthy controls.
  arm group label: Lung Cancer Patients
  description: patients undergoing surgery for histologically proven NSCLC
  arm group label: Healthy Control Patients
  description: patients undergoing surgery for benign extra-thoracic disease who had undergone chest X-rays/chest CT-scan, proved to be negative during preoperative evaluation.
  intervention type: Device
  intervention name: Portable GC device for brath analysis
  description: Patients were asked to orally exhale 1-2 L breath into a 5 L Tedlar bag via a one-way mouthpiece and Nafion filter for moisture removal, as shown in Figure 1B. The process usually takes about a few minutes. The breath analysis took place either in-situ immediately after the breath sample collection or within 24 h of breath collection. The Tedlar bags were stored under ambient condition until analyzed. During the breath analysis, the Tedlar bag was connected to the sampling port of the portable GC (Figure 1C). Approximately 350 mL of breath was pulled from the Tedlar bag into the GC for analysis. The GC operation was controlled using LabView via a laptop. The total assay time was 30 min, including 5 min of breath sampling time from the Tedlar bag at a flow rate of 70 mL/min (see the blue path in Figure 1A), 5 min of desorption/transfer time, 10 min of chromatographic separation time (see the orange path in Figure 1A), and 10 min of GC system cleaning time.
  arm group label: Healthy Control Patients
  arm group label: Lung Cancer Patients
  Breath from the patients, retained for a maximum of 24h
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Giuseppe Marulli, MD, PhD
  role: Study Director
  affiliation: Humanitas Research Hospital
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: No
  ipd description: On request alla data will be available