<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/NCT03793088</url>
  </required_header>
  <id_info>
    <org_study_id>XC3-GCTA-2018</org_study_id>
    <nct_id>NCT03793088</nct_id>
  </id_info>
  <brief_title>A Patient-Centric Platform Trial for Precision Oncology</brief_title>
  <acronym>XCELSIOR</acronym>
  <official_title>xCures/CancerCommons Enhanced Learning Treatment Selection and Analysis With Outcomes Research (XCELSIOR) Study: A Patient-Centric Platform Trial for Precision Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>xCures</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Commons</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Musella Foundation for Brain Tumor Research and Information, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pediatric Oncology Experimental Therapeutics Investigators Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>xCures</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      XCELSIOR is a non-interventional data registry. Information about treatments, treatment&#xD;
      decisions and rationale, and patient outcomes including safety and effectiveness of&#xD;
      anti-cancer therapy and associated supportive care will be collected for analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      XCELSIOR is patient-centric study for the registration of cancer patients, operations of a&#xD;
      virtual tumor board, insight capture in clinical decision making, and collection of&#xD;
      longitudinal, observational data in a cancer registry. Patient intake into XCELSIOR will&#xD;
      occur through the Cancer Commons Web portal. This includes consent to participate in the data&#xD;
      registry, including the collection and review of medical information by a Virtual Tumor&#xD;
      Board, generation of patient-specific treatment options with supporting rationale, access to&#xD;
      treatment access support services, and inclusion into a registry study that includes safety&#xD;
      and efficacy outcomes tracking. Patients will be treated and tracked in their original&#xD;
      treatment setting and the data generated will form part of a systematic framework combining&#xD;
      expert judgment with artificial intelligence to maximize information gain and improve&#xD;
      treatment option set development for individual cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>5 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Oncology</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will initially include up to 10,000 adult and pediatric patients with&#xD;
        recalcitrant or advanced cancers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female patients with known or suspected recalcitrant or advanced cancer&#xD;
             are eligible to enroll through the Cancer Commons Website&#xD;
&#xD;
          -  Patients with any performance status, comorbidity or disease severity are eligible&#xD;
&#xD;
          -  Patients or their legally-authorized representative must be willing and able to&#xD;
             provide written, informed consent (and assent, if applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must be a resident of or receiving care within the United States or US&#xD;
             territories.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Shapiro</last_name>
    <role>Principal Investigator</role>
    <affiliation>xCures / Cancer Commons</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bryan J Federowicz</last_name>
    <phone>707-641-4475</phone>
    <email>bfederowicz@xcures.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Commons</name>
      <address>
        <city>Los Altos</city>
        <state>California</state>
        <zip>94022</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bryan Federowicz</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.cancercommons.org/</url>
    <description>Cancer Commons Website</description>
  </link>
  <link>
    <url>https://www.xcures.com/patients/</url>
    <description>xCures Website</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glioblastoma</keyword>
  <keyword>Glioma</keyword>
  <keyword>Pancreatic Adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03793088/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03793088
org study id: XC3-GCTA-2018
nct id: NCT03793088
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
XCELSIOR is a non-interventional data registry. Information about treatments, treatment
      decisions and rationale, and patient outcomes including safety and effectiveness of
      anti-cancer therapy and associated supportive care will be collected for analysis.
XCELSIOR is patient-centric study for the registration of cancer patients, operations of a
      virtual tumor board, insight capture in clinical decision making, and collection of
      longitudinal, observational data in a cancer registry. Patient intake into XCELSIOR will
      occur through the Cancer Commons Web portal. This includes consent to participate in the data
      registry, including the collection and review of medical information by a Virtual Tumor
      Board, generation of patient-specific treatment options with supporting rationale, access to
      treatment access support services, and inclusion into a registry study that includes safety
      and efficacy outcomes tracking. Patients will be treated and tracked in their original
      treatment setting and the data generated will form part of a systematic framework combining
      expert judgment with artificial intelligence to maximize information gain and improve
      treatment option set development for individual cancer patients.
observational model: Cohort
time perspective: Prospective
measure: Progression Free Survival (PFS)
time frame: 5 Years
measure: Overall Survival (OS)
time frame: 5 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Shapiro
role: Principal Investigator
affiliation: xCures / Cancer Commons
last name: Bryan J Federowicz
phone: 707-641-4475
email: bfederowicz@xcures.com
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.cancercommons.org/
description: Cancer Commons Website
url: https://www.xcures.com/patients/
description: xCures Website
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Undecided
provided document: 