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/NCT05987709</url>
    </required_header>
    <id_info>
      <org_study_id>KPNW Guardant [1866832-1]</org_study_id>
      <nct_id>NCT05987709</nct_id>
    </id_info>
    <brief_title>Study of Colorectal Cancer Screening Options</brief_title>
    <official_title>Study of Colorectal Cancer Screening Options</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaiser Permanente</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaiser Permanente</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 investigators propose to evaluate Guardant Health's commercially available colorectal&#xD;
        cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC&#xD;
        screening.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators propose to evaluate Guardant Health's commercially available colorectal&#xD;
        cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC&#xD;
        screening.&#xD;
  &#xD;
        Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who&#xD;
        are non-adherent after receiving stool test outreach, who have an upcoming clinical&#xD;
        appointment, and who are offered a commercially available colorectal cancer blood test versus&#xD;
        usual care (i.e. reminder to complete stool testing during their clinical appointment).&#xD;
  &#xD;
        Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the&#xD;
        test (based on available test performance characteristics) and willingness to obtain/offer&#xD;
        the test on an on-going basis, based on qualitative interviews; assess preliminary rates of&#xD;
        follow-up colonoscopy completion (after an initial abnormal test result) among participants&#xD;
        allocated to the blood test vs. usual care condition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 17, 2022</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assess colorectal cancer screening completion</measure>
      <time_frame>Within 3 months of patient identification</time_frame>
      <description>Assess the proportion who received any CRC screening test (blood draw, FIT or FIT-DNA, or flexible sigmoidoscopy or colonoscopy) within 3 months of eligibility determination among eligible individuals in the blood test and usual care groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess the proportion who completed follow-up testing.</measure>
      <time_frame>Within 6 months of abnormal FIT test</time_frame>
      <description>Assess the proportion who completed follow-up colonoscopy within 6 months of their result among individuals with an abnormal non-invasive test result; comparing the blood test and usual care groups.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">400</enrollment>
    <condition>Colon Cancer</condition>
    <arm_group>
      <arm_group_label>Guardant Shield Blood Test</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients will have the Guardant Shield blood test for colorectal cancer screening.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>GuardantSHIELD Blood Test</intervention_name>
      <description>The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC</description>
      <arm_group_label>Guardant Shield Blood Test</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 45-75&#xD;
  &#xD;
            -  Received a FIT test in the last 3-9 months yet did not return their FIT&#xD;
  &#xD;
            -  Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6&#xD;
               weeks&#xD;
  &#xD;
            -  Able and willing to provide informed consent if in the intervention arm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  On KPNW's do not contact list&#xD;
  &#xD;
            -  Having a legal authorized representative&#xD;
  &#xD;
            -  Non-English speakers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gloria Coronado, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kaiser Permanente</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kaiser Permanente Northwest</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97227</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Colon Cancer Screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colonic 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>
  
  
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/NCT05987709
  org study id: KPNW Guardant [1866832-1]
  nct id: NCT05987709
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators propose to evaluate Guardant Health's commercially available colorectal
        cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC
        screening.
  The investigators propose to evaluate Guardant Health's commercially available colorectal
        cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC
        screening.
  
        Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who
        are non-adherent after receiving stool test outreach, who have an upcoming clinical
        appointment, and who are offered a commercially available colorectal cancer blood test versus
        usual care (i.e. reminder to complete stool testing during their clinical appointment).
  
        Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the
        test (based on available test performance characteristics) and willingness to obtain/offer
        the test on an on-going basis, based on qualitative interviews; assess preliminary rates of
        follow-up colonoscopy completion (after an initial abnormal test result) among participants
        allocated to the blood test vs. usual care condition.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Assess colorectal cancer screening completion
  time frame: Within 3 months of patient identification
  description: Assess the proportion who received any CRC screening test (blood draw, FIT or FIT-DNA, or flexible sigmoidoscopy or colonoscopy) within 3 months of eligibility determination among eligible individuals in the blood test and usual care groups.
  measure: Assess the proportion who completed follow-up testing.
  time frame: Within 6 months of abnormal FIT test
  description: Assess the proportion who completed follow-up colonoscopy within 6 months of their result among individuals with an abnormal non-invasive test result; comparing the blood test and usual care groups.
  arm group label: Guardant Shield Blood Test
  arm group type: Other
  description: Patients will have the Guardant Shield blood test for colorectal cancer screening.
  arm group label: Standard of Care
  arm group type: No Intervention
  description: Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
  intervention type: Diagnostic Test
  intervention name: GuardantSHIELD Blood Test
  description: The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC
  arm group label: Guardant Shield Blood Test
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gloria Coronado, PhD
  role: Principal Investigator
  affiliation: Kaiser Permanente
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Colonic Neoplasms
  sharing ipd: No