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/NCT06018753</url>
    </required_header>
    <id_info>
      <org_study_id>TP-CA-005</org_study_id>
      <secondary_id>Pro00073040</secondary_id>
      <nct_id>NCT06018753</nct_id>
    </id_info>
    <brief_title>Umbrella Study for Analysis of Data Related to Patients With Cancer</brief_title>
    <acronym>Polaris</acronym>
    <official_title>Umbrella Study for Analysis of Data Related to Patients With Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tempus Labs</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tempus Labs</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>
        This study is a multisite, minimal risk, non-interventional study using patient electronic&#xD;
        health record data collected as part of standard of care to answer cohort-based research&#xD;
        questions and create robust real-world data sets.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        One key purpose of the Study is to collect data that may be used for a wide range of&#xD;
        scientific questions and real-world insights.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2028</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Provide RWD/E Datasets to Research Collaborators to Support Development</measure>
      <time_frame>5 years</time_frame>
      <description>Use data analysis to enable deeper understanding of patient population characteristics and outcomes to more accurately assess clinical trial feasibility and optimize trial design.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provide RWD/E Datasets to Research Collaborators to Support Regulatory</measure>
      <time_frame>5 years</time_frame>
      <description>Use data analysis to generate supplemental data for new accelerated approval pathway filings and provide real world control arms where necessary.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provide RWD/E Datasets to Research Collaborators to Support Commercialization</measure>
      <time_frame>5 years</time_frame>
      <description>Use data analysis to enable more precise characterization of biomarker testing rates, factors influencing access to testing, and uptake of recently approved therapies to inform commercial strategy for pharmaceutical companies and generate evidence for payors.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provide RWD/E Datasets to Research Collaborators to Support Phase IV Surveillance</measure>
      <time_frame>5 years</time_frame>
      <description>Use data analysis to support post approval understanding of longer term side effects that may not be sufficiently detected via randomized clinical trials.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provide RWD/E Datasets to Research Collaborators to Support Real-World Insights</measure>
      <time_frame>5 years</time_frame>
      <description>Use data analysis to further understanding of variations in patient care across the US to help ensure patients have access to optimal testing and treatment.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Patients with cancer</arm_group_label>
      <description>No intervention or sample collection is required on the study.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The population of subjects targeted are: 1) those who have cancer, and 2) those for whom&#xD;
          medical records are available.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects must be diagnosed with cancer&#xD;
  &#xD;
            -  Medical records available to meet cohort requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Anjali Avadhani, MD</last_name>
      <role>Study Director</role>
      <affiliation>Tempus Labs, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lauren Lopez</last_name>
      <phone>tel:8007394137</phone>
      <email>polaris@tempus.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Data Analysis</keyword>
    <keyword>Master Protocol</keyword>
    <keyword>Oncology</keyword>
    <keyword>Retrospective</keyword>
    <!-- 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/NCT06018753
  org study id: TP-CA-005
  secondary id: Pro00073040
  nct id: NCT06018753
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multisite, minimal risk, non-interventional study using patient electronic
        health record data collected as part of standard of care to answer cohort-based research
        questions and create robust real-world data sets.
  One key purpose of the Study is to collect data that may be used for a wide range of
        scientific questions and real-world insights.
  observational model: Cohort
  time perspective: Retrospective
  measure: Provide RWD/E Datasets to Research Collaborators to Support Development
  time frame: 5 years
  description: Use data analysis to enable deeper understanding of patient population characteristics and outcomes to more accurately assess clinical trial feasibility and optimize trial design.
  measure: Provide RWD/E Datasets to Research Collaborators to Support Regulatory
  time frame: 5 years
  description: Use data analysis to generate supplemental data for new accelerated approval pathway filings and provide real world control arms where necessary.
  measure: Provide RWD/E Datasets to Research Collaborators to Support Commercialization
  time frame: 5 years
  description: Use data analysis to enable more precise characterization of biomarker testing rates, factors influencing access to testing, and uptake of recently approved therapies to inform commercial strategy for pharmaceutical companies and generate evidence for payors.
  measure: Provide RWD/E Datasets to Research Collaborators to Support Phase IV Surveillance
  time frame: 5 years
  description: Use data analysis to support post approval understanding of longer term side effects that may not be sufficiently detected via randomized clinical trials.
  measure: Provide RWD/E Datasets to Research Collaborators to Support Real-World Insights
  time frame: 5 years
  description: Use data analysis to further understanding of variations in patient care across the US to help ensure patients have access to optimal testing and treatment.
  arm group label: Patients with cancer
  description: No intervention or sample collection is required on the study.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Anjali Avadhani, MD
  role: Study Director
  affiliation: Tempus Labs, Inc.
  last name: Lauren Lopez
  phone: tel:8007394137
  email: polaris@tempus.com
  responsible party type: Sponsor