<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/NCT01700452</url>
  </required_header>
  <id_info>
    <org_study_id>LCD Test 17Jul2012</org_study_id>
    <secondary_id>Revision 3</secondary_id>
    <nct_id>NCT01700452</nct_id>
  </id_info>
  <brief_title>Diagnostic Study for Lung Cancer Detection Test</brief_title>
  <official_title>Clinical Study of BioView Target -FISH Lung Cancer Detection Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioview, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bioview, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early detection of lung cancer and early removal of the cancer nodules facilitates the&#xD;
      diagnosis and treatment. However, not all nodules are malignant. Currently the standard&#xD;
      method to diagnose lung cancer is to remove any suspicious nodules from the lung in a&#xD;
      surgical procedure.&#xD;
&#xD;
      This study is being conducted to evaluate the performance of a laboratory test to detect&#xD;
      changes in lung cells that might be an early indicator of lung cancer. The test uses mucus&#xD;
      (sputum) which is collected in a non-invasive method. This study will compare the results of&#xD;
      the lung biopsy with the laboratory test to determine if the test can detect cancer or the&#xD;
      lack of cancer.&#xD;
&#xD;
      The laboratory test will not be shared with the treating physician or the patient as the&#xD;
      current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be&#xD;
      enrolled in the study. There is one visit involved and includes the collection of a sputum&#xD;
      specimen by coughing into a cup. The medical records of patients who are negative for cancer&#xD;
      by biopsy will be reviewed for 2 years to detect any changes in diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being conducted to evaluate the performance of a laboratory test to detect&#xD;
      changes in lung cells that might be an early indicator of lung cancer. The test uses mucus&#xD;
      (sputum) which is collected in a non-invasive method. This study will compare the results of&#xD;
      the lung biopsy with the laboratory test to determine if the test can detect cancer or the&#xD;
      lack of cancer.&#xD;
&#xD;
      The laboratory test will not be shared with the treating physician or the patient as the&#xD;
      current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be&#xD;
      enrolled in the study. There is one visit involved and includes the collection of a sputum&#xD;
      specimen by coughing into a cup. The medical records of patients who are negative for cancer&#xD;
      by biopsy will be reviewed for 2 years to detect any changes in diagnosis.&#xD;
&#xD;
      The results of the test will not be provided to the subject, the investigator and will not be&#xD;
      used to diagnose or treat the subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy</measure>
    <time_frame>2 weeks following sputum collection</time_frame>
    <description>Subjects suspected of having of having lung cancer and who are to undergo biopsy will undergo sputum sampling. The sputum will be assayed using the BioView test kit. Biopsy results will be compared with the assay results, each being a dichotomous response (positive or negative for cancer by biopsy, positive or negative assay result using client-supplied cut-off). Since the assay may detect cancer before a biopsy is positive or because the sputum sampling may be more representative of the condition of the lung than just the biopsied nodule, it will be necessary to follow thte negative biopsy subjects for up to two years to either rule in or rule out lung cancer.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">173</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>patients suspected of having lung cancer</arm_group_label>
    <description>Subjects presenting with 0.8 - 3 cm solitary pulmonary nodules with high probability for malignance. The subject must be scheduled for a lung biopsy procedure to determine clinical diagnosis.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      sputum specimens, fixed and stained for diagnostic testing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects will be selected from pulmonary clinics and physician's practice in community&#xD;
        hospital settings.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with 0.8-3 cm solitary pulmonary nodules with high probability for malignancy&#xD;
&#xD;
          -  Candidate is scheduled to undergo lung biopsy procedure to determine clinical&#xD;
             diagnosis, such as Bronchoscope biopsy, Electromagnetic Navigation Bronchoscopy, fiber&#xD;
             optic Bronchoscopy, Needle biopsy, CT guided, Percutaneous Transthoracic Needle&#xD;
             biopsy, Transthoracic Needle Biopsy, Open biopsy for Diagnostic Resection or&#xD;
             Video-Assisted Thorascopic Surgery.&#xD;
&#xD;
          -  Candidate who is capable of undergoing sputum induction.&#xD;
&#xD;
          -  Ability to understand the investigational nature of the study and sign the informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who pose a high clinical risk for diagnostic bronchoscopy or transthoracic&#xD;
             biopsy for definitive diagnosis.&#xD;
&#xD;
          -  Subjects already diagnosed with lung cancer, or previously treated for lung cancer.&#xD;
&#xD;
          -  Subjects who experienced pneumonia within last 12 weeks.&#xD;
&#xD;
          -  Subjects who experienced an acute respiratory infection within the last 2 weeks&#xD;
&#xD;
          -  Cases without sufficient documentation of diagnosis or follow-up will not be included.&#xD;
&#xD;
          -  Treatment for, or evidence of any cancer other than nonmelanoma skin cancer or&#xD;
             carcinoma in situ within the last 3 years.&#xD;
&#xD;
          -  Subject who lack the capacity to consent.&#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>Alan Schwebel, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bioview, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Greater Los Angeles Health System</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederick Memorial Hospital, Regional Cancer Center</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center Thoracic Cancer Research and Detection Center</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>July 18, 2016</last_update_submitted>
  <last_update_submitted_qc>July 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>Pulmonary nodules</keyword>
  <keyword>FISH Test</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/NCT01700452
org study id: LCD Test 17Jul2012
secondary id: Revision 3
nct id: NCT01700452
lead sponsor: 
has dmc: No
Early detection of lung cancer and early removal of the cancer nodules facilitates the
      diagnosis and treatment. However, not all nodules are malignant. Currently the standard
      method to diagnose lung cancer is to remove any suspicious nodules from the lung in a
      surgical procedure.

      This study is being conducted to evaluate the performance of a laboratory test to detect
      changes in lung cells that might be an early indicator of lung cancer. The test uses mucus
      (sputum) which is collected in a non-invasive method. This study will compare the results of
      the lung biopsy with the laboratory test to determine if the test can detect cancer or the
      lack of cancer.

      The laboratory test will not be shared with the treating physician or the patient as the
      current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be
      enrolled in the study. There is one visit involved and includes the collection of a sputum
      specimen by coughing into a cup. The medical records of patients who are negative for cancer
      by biopsy will be reviewed for 2 years to detect any changes in diagnosis.
This study is being conducted to evaluate the performance of a laboratory test to detect
      changes in lung cells that might be an early indicator of lung cancer. The test uses mucus
      (sputum) which is collected in a non-invasive method. This study will compare the results of
      the lung biopsy with the laboratory test to determine if the test can detect cancer or the
      lack of cancer.

      The laboratory test will not be shared with the treating physician or the patient as the
      current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be
      enrolled in the study. There is one visit involved and includes the collection of a sputum
      specimen by coughing into a cup. The medical records of patients who are negative for cancer
      by biopsy will be reviewed for 2 years to detect any changes in diagnosis.

      The results of the test will not be provided to the subject, the investigator and will not be
      used to diagnose or treat the subject.
observational model: Cohort
time perspective: Prospective
measure: Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy
time frame: 2 weeks following sputum collection
description: Subjects suspected of having of having lung cancer and who are to undergo biopsy will undergo sputum sampling. The sputum will be assayed using the BioView test kit. Biopsy results will be compared with the assay results, each being a dichotomous response (positive or negative for cancer by biopsy, positive or negative assay result using client-supplied cut-off). Since the assay may detect cancer before a biopsy is positive or because the sputum sampling may be more representative of the condition of the lung than just the biopsied nodule, it will be necessary to follow thte negative biopsy subjects for up to two years to either rule in or rule out lung cancer.
arm group label: patients suspected of having lung cancer
description: Subjects presenting with 0.8 - 3 cm solitary pulmonary nodules with high probability for malignance. The subject must be scheduled for a lung biopsy procedure to determine clinical diagnosis.
sputum specimens, fixed and stained for diagnostic testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan Schwebel, PhD
role: Study Director
affiliation: Bioview, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No