<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/NCT03766958</url>
  </required_header>
  <id_info>
    <org_study_id>BDX-CD-002</org_study_id>
    <nct_id>NCT03766958</nct_id>
  </id_info>
  <brief_title>A Registry to Evaluate the Performance of the BDX-XL2 Test</brief_title>
  <acronym>ORACLE</acronym>
  <official_title>An Observational Registry Study to Evaluate the Performance of the BDX-XL2 Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biodesix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biodesix, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test;&#xD;
      specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and&#xD;
      surgeries, on benign lung nodules while not significantly increasing the number of malignant&#xD;
      lung nodules routed to CT surveillance. Clinical data will be collected from participating&#xD;
      patients to evaluate the impact of the BDX-XL2 test when used in the clinical management of&#xD;
      recently identified lung nodules assessed to have a low to moderate risk of cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 16, 2018</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">842</enrollment>
  <condition>Nodule Solitary Pulmonary</condition>
  <condition>NSCLC</condition>
  <arm_group>
    <arm_group_label>Registry Patients With Nodify Lung Results</arm_group_label>
    <description>Patients providing consent to have data collected to observe how Nodify Lung results were used in the clinical management of their lung nodules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contemporaneous Group Without Nodify Lung</arm_group_label>
    <description>Contemporaneous group who did not have Nodify Lung test results for use in the clinical management of their lung nodules.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be identified from the patient populations of participating pulmonary&#xD;
        medicine practices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has provided informed consent to participate in the registry and agrees to&#xD;
             comply with all protocol requirements.&#xD;
&#xD;
          2. Patient meets the criteria for the intended use population of Nodify Lung testing:&#xD;
&#xD;
               -  Patient is &gt; 40 years of age at the time of the discovery of the lung nodule of&#xD;
                  concern.&#xD;
&#xD;
               -  The maximal dimension of the patient's lung nodule of concern is &gt; 8mm and &lt;&#xD;
                  30mm.&#xD;
&#xD;
               -  The pre-test risk of cancer as determined by the Mayo risk prediction algorithm&#xD;
                  is 65% or less.&#xD;
&#xD;
          3. The first CT scan identifying the lung nodule of concern was performed within 60 days&#xD;
             of patient enrollment in the registry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nodule work-up before the time of patient enrollment indicating any attempted or&#xD;
             completed biopsy procedure after the first CT scan identifying the lung nodule of&#xD;
             concern.&#xD;
&#xD;
          2. High risk per physician assessment (i.e. &gt; 65% by physician pCA)&#xD;
&#xD;
          3. Current diagnosis of any active cancer.&#xD;
&#xD;
          4. Prior diagnosis of lung cancer.&#xD;
&#xD;
          5. Prior diagnosis of any cancer within 5 years of lung nodule detection, except for&#xD;
             non-melanomatous skin cancer.&#xD;
&#xD;
          6. Concurrent participation in any unrelated clinical trial that may impact or alter the&#xD;
             management of the patient's nodule of concern.&#xD;
&#xD;
          7. Any illness or factor that will prevent compliance with follow-up as recommended.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leona Hamrick, DHSc, PA-C, MSL-BC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biodesix, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Pritchett, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pinehurst Medical Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Health</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amicis Research Center</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pueblo Pulmonary Associates</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stamford Health</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hospital</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Research Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nevada, Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27858</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinehurst Medical Clinic</name>
      <address>
        <city>Pinehurst</city>
        <state>North Carolina</state>
        <zip>28374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Research Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oregon Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates of Central PA/Penn Highlands Hospital</name>
      <address>
        <city>DuBois</city>
        <state>Pennsylvania</state>
        <zip>15801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peacehealth</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03766958
org study id: BDX-CD-002
nct id: NCT03766958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test;
      specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and
      surgeries, on benign lung nodules while not significantly increasing the number of malignant
      lung nodules routed to CT surveillance. Clinical data will be collected from participating
      patients to evaluate the impact of the BDX-XL2 test when used in the clinical management of
      recently identified lung nodules assessed to have a low to moderate risk of cancer.
observational model: Cohort
time perspective: Prospective
measure: Statistically significant change in the proportion of benign lung nodules managed by Nodify Lung experiencing invasive procedures.
time frame: Up to 2 years
arm group label: Registry Patients With Nodify Lung Results
description: Patients providing consent to have data collected to observe how Nodify Lung results were used in the clinical management of their lung nodules.
arm group label: Contemporaneous Group Without Nodify Lung
description: Contemporaneous group who did not have Nodify Lung test results for use in the clinical management of their lung nodules.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Leona Hamrick, DHSc, PA-C, MSL-BC
role: Principal Investigator
affiliation: Biodesix, Inc.
last name: Michael Pritchett, DO
role: Principal Investigator
affiliation: Pinehurst Medical Clinic
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country: United States
responsible party type: Sponsor