<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/NCT04474613</url>
  </required_header>
  <id_info>
    <org_study_id>CASE1520</org_study_id>
    <nct_id>NCT04474613</nct_id>
  </id_info>
  <brief_title>Liquid Biopsy to Reduce Time to Treatment for Advanced Nonsquamous NSCLC Diagnosed at Outside Sites</brief_title>
  <official_title>Use of Liquid Biopsy to Reduce Time to Treatment for Patients With Advanced Nonsquamous Non-small Cell Lung Cancer Diagnosed at Outside Sites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if liquid biopsies will reduce time to begin&#xD;
      treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test&#xD;
      done on a sample of blood to look for cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable&#xD;
      mutations will be considered for this study. The primary objective of this prospective study&#xD;
      is to examine if using liquid biopsy can reduce time to treatment (TTT) in external&#xD;
      participants with NSCLC. Secondary objectives examined will include time to actionable&#xD;
      genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate&#xD;
      of appropriate guideline-directed therapy based upon testing results.&#xD;
&#xD;
      A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional&#xD;
      biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A&#xD;
      liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with&#xD;
      NSCLC. By studying this, doctors may be better able to determine if this will be beneficial&#xD;
      and result in less time taken to treat cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TTT measured in days</measure>
    <time_frame>An average of 30 days</time_frame>
    <description>TTT measured in days - TTT will be summarized using mean, SD, and range. One sample t-test will be used to compare observed TTT against the null (30 days).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to actionable genetic testing results</measure>
    <time_frame>An average of 30 days</time_frame>
    <description>Time to actionable genetic testing results (ctDNA or tissue). Negative results with ctDNA testing will still require tissue confirmation, while positive results will be considered actionable without further testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of actionable biomarker discovery</measure>
    <time_frame>An average of 30 days</time_frame>
    <description>Rate of actionable biomarker discovery, defined as the percentage of tested patients who have a detected genetic marker that is associated with either 1) an FDA-approved targeted treatment or 2) a targeted treatment available through a clinical trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of appropriate guideline-directed therapy based upon testing results</measure>
    <time_frame>An average of 30 days</time_frame>
    <description>Rate of appropriate guideline-directed therapy based upon testing results</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Liquid biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A liquid biopsy is a test will be done on a sample of blood to look for cancer cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Liquid biopsy</intervention_name>
    <description>Liquid biopsy done on a blood draw, taking approximately 7 days</description>
    <arm_group_label>Liquid biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the&#xD;
             Cleveland Clinic Taussig Cancer Center from outside centers without prior testing&#xD;
             results available for targetable genetic alterations&#xD;
&#xD;
          -  Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic&#xD;
             therapy at an outside site while maintaining either intermittent follow up at&#xD;
             Cleveland Clinic or with electronic health record access through Care Everywhere.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy for this diagnosis of NSCLC&#xD;
&#xD;
          -  Prior adequate molecular testing done for the current diagnosis of NSCLC&#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>Nathan Pennell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>All IPD that underlies the publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Shortly after completion of the study which is to take approximately one year</ipd_time_frame>
  </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/NCT04474613
org study id: CASE1520
nct id: NCT04474613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine if liquid biopsies will reduce time to begin
      treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test
      done on a sample of blood to look for cancer cells.
Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable
      mutations will be considered for this study. The primary objective of this prospective study
      is to examine if using liquid biopsy can reduce time to treatment (TTT) in external
      participants with NSCLC. Secondary objectives examined will include time to actionable
      genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate
      of appropriate guideline-directed therapy based upon testing results.

      A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional
      biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A
      liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with
      NSCLC. By studying this, doctors may be better able to determine if this will be beneficial
      and result in less time taken to treat cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: TTT measured in days
time frame: An average of 30 days
description: TTT measured in days - TTT will be summarized using mean, SD, and range. One sample t-test will be used to compare observed TTT against the null (30 days).
measure: Time to actionable genetic testing results
time frame: An average of 30 days
description: Time to actionable genetic testing results (ctDNA or tissue). Negative results with ctDNA testing will still require tissue confirmation, while positive results will be considered actionable without further testing.
measure: Rate of actionable biomarker discovery
time frame: An average of 30 days
description: Rate of actionable biomarker discovery, defined as the percentage of tested patients who have a detected genetic marker that is associated with either 1) an FDA-approved targeted treatment or 2) a targeted treatment available through a clinical trial.
measure: Rate of appropriate guideline-directed therapy based upon testing results
time frame: An average of 30 days
description: Rate of appropriate guideline-directed therapy based upon testing results
arm group label: Liquid biopsy
arm group type: Experimental
description: A liquid biopsy is a test will be done on a sample of blood to look for cancer cells
intervention type: Diagnostic Test
intervention name: Liquid biopsy
description: Liquid biopsy done on a blood draw, taking approximately 7 days
arm group label: Liquid biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Pennell, MD, PhD
role: Principal Investigator
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes
ipd description: All IPD that underlies the publication
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Shortly after completion of the study which is to take approximately one year