<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/NCT03275688</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00121967</org_study_id>
    <nct_id>NCT03275688</nct_id>
  </id_info>
  <brief_title>NanoSpectrometer Biomarker Discovery and Confirmation Study</brief_title>
  <official_title>NanoSpectrometer Biomarker Discovery and Confirmation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanobeak Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will evaluate exhaled volatile organic compounds (VOC's) in the breath of&#xD;
      participants with stage 1 lung cancer, their house-mates, and matched controls. The goal of&#xD;
      the study is to identify VOC fingerprints that are only detectable in those with stage 1 lung&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung cancer is by far the leading cause of cancer death in the United States. More people die&#xD;
      annually of lung cancer than of colon, breast, and prostate cancers combined. Worldwide it is&#xD;
      already the leading cause of cancer death among males, and with smoking rates substantially&#xD;
      higher in developing countries relative to the United States the worldwide burden of lung&#xD;
      cancer is projected to increase considerably in the future.&#xD;
&#xD;
      For lung cancer, as for many cancers, early diagnosis allowing for full resection offers the&#xD;
      greatest chance for long-term survival, but unfortunately these individuals currently&#xD;
      constitute only a minority of the lung-cancer population. Screening technologies that allow&#xD;
      for the earliest detection of lung cancer would therefore have tremendous potential to&#xD;
      substantially improve outcomes. Recently, and for the first time, a screening test for lung&#xD;
      cancer of high risk individuals has been recommended by the US Preventive Services Task&#xD;
      Force, as well as others, for the reduction of lung cancer mortality. This recommendation was&#xD;
      based primarily on the results of the National Lung Screening Trial (NLST) that randomized&#xD;
      over 53,000 individuals considered at high risk for lung cancer to 3 annual screenings with&#xD;
      either low-dose CT (LDCT) or a chest x-ray and then followed for a median of 6.5 years. In&#xD;
      this study LDCT scanning was associated with a statistically significant 20% relative&#xD;
      decrease in lung cancer mortality, and a smaller, but still significant 6.7% decrease in&#xD;
      overall mortality. Despite these encouraging results of LDCT, as a screening tool it has&#xD;
      substantial limitations. Beyond the costs, inconvenience and radiation exposure associated&#xD;
      with LDCT, its performance characteristics are far from optimal. For example, nearly a&#xD;
      quarter of the LDCT population had a positive screening test, with the vast majority - 96.4%&#xD;
      - proving to be false-positive. With a positive predictive value of &lt;4% LDCT screening will&#xD;
      lead to a great number of unnecessary diagnostic procedures as well as substantial anxiety in&#xD;
      the screened population and their family.&#xD;
&#xD;
      Breath analytics is a new and very promising tool for diagnosing lung cancer, as well as&#xD;
      multiple other conditions. Previous studies identified that dog's heightened olfactory senses&#xD;
      were able to detect cancer in an individual's breath with an accuracy of nearly 100%. Since&#xD;
      then attempts have been made to mimic canine capabilities with &quot;electronic noses&quot; to detect&#xD;
      and quantitate the nearly 3000 compounds, many in the parts per billion or even parts per&#xD;
      trillion ranges, in exhaled breath. Early studies of these technologies support great&#xD;
      potential as a diagnostic and screening tool. As a screening tool it could be ideal as it is&#xD;
      noninvasive, painless and free of any undesirable side effects. In addition, new advances in&#xD;
      nanotechnology have allowed these extremely sensitive detection technologies to be&#xD;
      miniaturized to the point that they can be linked to a smartphone, providing future&#xD;
      possibilities to almost continuously surveil individuals for the development of lung cancer&#xD;
      and other life-threatening conditions. This study is concerned with comparing the&#xD;
      concentrations of volatile organic compounds (VOCs) in the breath of lung cancer patients&#xD;
      (cases) and lung-cancer-free individuals (controls).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim analysis showed sample size sufficient for final analysis&#xD;
  </why_stopped>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">July 6, 2020</completion_date>
  <primary_completion_date type="Actual">July 6, 2020</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>Volatile organic compounds present in our cases but not controls.</measure>
    <time_frame>1.5 years</time_frame>
    <description>Volatile organic compounds will be measured between the cases and both types of controls. We will report the different volatile organic compound fingerprints that are present in cases and not in controls.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">332</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Stage 1 Lung Cancer (Case)</arm_group_label>
    <description>These are the participants with identified stage 1 lung cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 1 Control</arm_group_label>
    <description>These are participants who have similar clinical characteristics as our cases, but do not have any history of cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Control</arm_group_label>
    <description>These are housemates of the participants with stage 1 lung cancer (cases).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath Analysis</intervention_name>
    <description>Breath will be analyzed in all three groups using gas chromatography mass spectrometry.</description>
    <arm_group_label>Stage 1 Lung Cancer (Case)</arm_group_label>
    <arm_group_label>Type 1 Control</arm_group_label>
    <arm_group_label>Type 2 Control</arm_group_label>
    <other_name>Gas Chromatography Mass Spectrometry</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Breath sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of three groups. Our cases will be those who have been&#xD;
        diagnosed with stage 1 lung cancer. Our type 1 controls will consist of participants who do&#xD;
        not have lung cancer, but otherwise have similar clinical characteristics of our cases. the&#xD;
        type 2 controls will be people who live in the same house as our stage 1 lung cancer&#xD;
        patients (cases).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18 and over with diagnosed Stage 1 Lung Cancer (cases)&#xD;
&#xD;
          -  Adults age 18 and over without Lung cancer (type 1 controls)&#xD;
&#xD;
          -  Adults age 18 and over who live in the same environment as the cases (type 2 controls)&#xD;
&#xD;
        Exclusion Criteria N/A&#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>Lonny Yarmus, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung cancer</keyword>
  <keyword>volatile organic compound</keyword>
  <keyword>screening</keyword>
  <keyword>VOC</keyword>
  <keyword>clinical trial</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>
  </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/NCT03275688
org study id: IRB00121967
nct id: NCT03275688
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate exhaled volatile organic compounds (VOC's) in the breath of
      participants with stage 1 lung cancer, their house-mates, and matched controls. The goal of
      the study is to identify VOC fingerprints that are only detectable in those with stage 1 lung
      cancer.
Lung cancer is by far the leading cause of cancer death in the United States. More people die
      annually of lung cancer than of colon, breast, and prostate cancers combined. Worldwide it is
      already the leading cause of cancer death among males, and with smoking rates substantially
      higher in developing countries relative to the United States the worldwide burden of lung
      cancer is projected to increase considerably in the future.

      For lung cancer, as for many cancers, early diagnosis allowing for full resection offers the
      greatest chance for long-term survival, but unfortunately these individuals currently
      constitute only a minority of the lung-cancer population. Screening technologies that allow
      for the earliest detection of lung cancer would therefore have tremendous potential to
      substantially improve outcomes. Recently, and for the first time, a screening test for lung
      cancer of high risk individuals has been recommended by the US Preventive Services Task
      Force, as well as others, for the reduction of lung cancer mortality. This recommendation was
      based primarily on the results of the National Lung Screening Trial (NLST) that randomized
      over 53,000 individuals considered at high risk for lung cancer to 3 annual screenings with
      either low-dose CT (LDCT) or a chest x-ray and then followed for a median of 6.5 years. In
      this study LDCT scanning was associated with a statistically significant 20% relative
      decrease in lung cancer mortality, and a smaller, but still significant 6.7% decrease in
      overall mortality. Despite these encouraging results of LDCT, as a screening tool it has
      substantial limitations. Beyond the costs, inconvenience and radiation exposure associated
      with LDCT, its performance characteristics are far from optimal. For example, nearly a
      quarter of the LDCT population had a positive screening test, with the vast majority - 96.4%
      - proving to be false-positive. With a positive predictive value of <4% LDCT screening will
      lead to a great number of unnecessary diagnostic procedures as well as substantial anxiety in
      the screened population and their family.

      Breath analytics is a new and very promising tool for diagnosing lung cancer, as well as
      multiple other conditions. Previous studies identified that dog's heightened olfactory senses
      were able to detect cancer in an individual's breath with an accuracy of nearly 100%. Since
      then attempts have been made to mimic canine capabilities with "electronic noses" to detect
      and quantitate the nearly 3000 compounds, many in the parts per billion or even parts per
      trillion ranges, in exhaled breath. Early studies of these technologies support great
      potential as a diagnostic and screening tool. As a screening tool it could be ideal as it is
      noninvasive, painless and free of any undesirable side effects. In addition, new advances in
      nanotechnology have allowed these extremely sensitive detection technologies to be
      miniaturized to the point that they can be linked to a smartphone, providing future
      possibilities to almost continuously surveil individuals for the development of lung cancer
      and other life-threatening conditions. This study is concerned with comparing the
      concentrations of volatile organic compounds (VOCs) in the breath of lung cancer patients
      (cases) and lung-cancer-free individuals (controls).
observational model: Case-Control
time perspective: Prospective
measure: Volatile organic compounds present in our cases but not controls.
time frame: 1.5 years
description: Volatile organic compounds will be measured between the cases and both types of controls. We will report the different volatile organic compound fingerprints that are present in cases and not in controls.
arm group label: Stage 1 Lung Cancer (Case)
description: These are the participants with identified stage 1 lung cancer.
arm group label: Type 1 Control
description: These are participants who have similar clinical characteristics as our cases, but do not have any history of cancer.
arm group label: Type 2 Control
description: These are housemates of the participants with stage 1 lung cancer (cases).
intervention type: Diagnostic Test
intervention name: Breath Analysis
description: Breath will be analyzed in all three groups using gas chromatography mass spectrometry.
arm group label: Stage 1 Lung Cancer (Case)
arm group label: Type 1 Control
arm group label: Type 2 Control
other name: Gas Chromatography Mass Spectrometry
Breath sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lonny Yarmus, DO
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No