<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/NCT03023202</url>
  </required_header>
  <id_info>
    <org_study_id>UW15068</org_study_id>
    <secondary_id>2015-1370</secondary_id>
    <secondary_id>P30CA014520</secondary_id>
    <secondary_id>A533400</secondary_id>
    <secondary_id>SMPH\UWCCC\GENERAL</secondary_id>
    <secondary_id>NCI-2019-06343</secondary_id>
    <secondary_id>1R37CA226526-01A1</secondary_id>
    <secondary_id>Protocol Version 11/22/2021</secondary_id>
    <nct_id>NCT03023202</nct_id>
  </id_info>
  <brief_title>UWCCC Molecular Tumor Board Registry</brief_title>
  <official_title>UWCCC Precision Medicine Molecular Tumor Board Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</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 seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor&#xD;
      Board, and to track patient outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 30, 2016</start_date>
  <completion_date type="Anticipated">March 2027</completion_date>
  <primary_completion_date type="Anticipated">March 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Frequency of acceptance of molecular tumor board recommendations</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>How often the molecular tumor board's recommendations are accepted</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Benefit from PMMTB recommended treatment</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Whether patients benefit from PMMTB recommended treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of mutations with protein overexpression</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Correlate mutations identified in tumor tissue with protein overexpression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations of mutations with circulating tumor DNA</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Correlate mutations identified in tumor tissue with circulating tumor DNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations of mutations with spheroid culture investigations</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Correlate mutations identified in tumor tissue with spheroid culture investigations</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Hematologic Neoplasms</condition>
  <condition>Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>PMMTB</arm_group_label>
    <description>This study of the PMMTB will include all patients &gt;= 18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor.&#xD;
All standard of care functions will be performed by standard procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PMMTB (Precision Medicine Molecular Tumor Board)</intervention_name>
    <description>PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.</description>
    <arm_group_label>PMMTB</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Subjects will be asked to give one blood sample and up to two tissue samples (one at&#xD;
      diagnossi &amp; one at progression of treatment, which are both standard clinical procedures).&#xD;
&#xD;
        -  Drawing 8 tsp of blood at the first clinic visit, DNA extraction from this blood,&#xD;
           additional testing on this blood.&#xD;
&#xD;
        -  Retention of residual tumor tissue for future research.&#xD;
&#xD;
        -  Collection of residual fresh tumor tissue [that was biopsied for clinical reasons], and&#xD;
           performing of genetic analyses/retention for future research.&#xD;
&#xD;
        -  Banking of data, blood, and biopsy tissue for future research.&#xD;
&#xD;
        -  Distribution of banked data/blood/biopsied tissue for research projects.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include all patients age ≥18 with clinically suspected or histologically&#xD;
        confirmed solid or hematological malignancy who will undergo genetic testing of their&#xD;
        tumor. It will require each patient to have the ability to understand and willingness to&#xD;
        sign a written informed consent document.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically suspected or histologically confirmed solid or hematological malignancy&#xD;
&#xD;
          -  Undergoing genetic testing of tumor&#xD;
&#xD;
          -  Ability to understand written informed consent document&#xD;
&#xD;
          -  Willingness to sign written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (age&lt;18 years) will be excluded due to a lack of expertise on the&#xD;
             molecular tumor committee&#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>Mark Burkard, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cancer Connect</last_name>
    <phone>8006228922</phone>
    <email>clinicaltrials@cancer.wisc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Connect</last_name>
      <phone>800-622-8922</phone>
      <email>clinicaltrials@cancer.wisc.edu</email>
    </contact>
    <investigator>
      <last_name>Mark Burkard, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>UW Carbone Cancer Center Home Page</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 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>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03023202
org study id: UW15068
secondary id: 2015-1370
secondary id: P30CA014520
secondary id: A533400
secondary id: SMPH\UWCCC\GENERAL
secondary id: NCI-2019-06343
secondary id: 1R37CA226526-01A1
secondary id: Protocol Version 11/22/2021
nct id: NCT03023202
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor
      Board, and to track patient outcomes.
observational model: Case-Only
time perspective: Prospective
measure: Frequency of acceptance of molecular tumor board recommendations
time frame: Up to 5 years
description: How often the molecular tumor board's recommendations are accepted
measure: Benefit from PMMTB recommended treatment
time frame: Up to 5 years
description: Whether patients benefit from PMMTB recommended treatment
measure: Correlation of mutations with protein overexpression
time frame: Up to 5 years
description: Correlate mutations identified in tumor tissue with protein overexpression
measure: Correlations of mutations with circulating tumor DNA
time frame: Up to 5 years
description: Correlate mutations identified in tumor tissue with circulating tumor DNA
measure: Correlations of mutations with spheroid culture investigations
time frame: Up to 5 years
description: Correlate mutations identified in tumor tissue with spheroid culture investigations
arm group label: PMMTB
description: This study of the PMMTB will include all patients >= 18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor.
All standard of care functions will be performed by standard procedures.
intervention type: Other
intervention name: PMMTB (Precision Medicine Molecular Tumor Board)
description: PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.
arm group label: PMMTB
Subjects will be asked to give one blood sample and up to two tissue samples (one at
      diagnossi & one at progression of treatment, which are both standard clinical procedures).

        -  Drawing 8 tsp of blood at the first clinic visit, DNA extraction from this blood,
           additional testing on this blood.

        -  Retention of residual tumor tissue for future research.

        -  Collection of residual fresh tumor tissue [that was biopsied for clinical reasons], and
           performing of genetic analyses/retention for future research.

        -  Banking of data, blood, and biopsy tissue for future research.

        -  Distribution of banked data/blood/biopsied tissue for research projects.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Burkard, MD, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Cancer Connect
phone: 8006228922
email: clinicaltrials@cancer.wisc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://cancer.wisc.edu/
description: UW Carbone Cancer Center Home Page
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms