<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/NCT03287063</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2017.094</org_study_id>
    <secondary_id>HUM00134165</secondary_id>
    <nct_id>NCT03287063</nct_id>
  </id_info>
  <brief_title>Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma</brief_title>
  <official_title>A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be&#xD;
      non-invasively identified using imaging phenotypes that identify regionally distinct areas of&#xD;
      tumor with genetic alterations that drive tumor resistance pathways. The researchers propose&#xD;
      a unique approach to assess initial GBM heterogeneity by performing histological and genomic&#xD;
      analysis of biopsies targeted by advanced MRI before treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Enrollment and/or interactions/interventions temporarily paused due to pending funding and&#xD;
    expected to resume in the future. This is not a suspension of IRB approval.&#xD;
  </why_stopped>
  <start_date type="Actual">July 5, 2018</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify candidate genes with differential expression in therapy-resistant imaging subvolumes</measure>
    <time_frame>At time of surgery</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Glioblastoma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tumor Biopsy</intervention_name>
    <description>Stereotactic biopsies will be performed prior to resection.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimens will be analyzed with next generation sequencing (NGS). The primary objective is to&#xD;
      identify candidate genes with differential expression in therapy-resistant imaging&#xD;
      subvolumes.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with glioblastoma eligible for surgical biopsy and/or resection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for&#xD;
             surgical biopsy and/or resection&#xD;
&#xD;
          -  Patients must be 18 years of age or older&#xD;
&#xD;
          -  Study-specific informed consent approved for this purpose by the IRB of the University&#xD;
             of Michigan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to undergo MRI&#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>Michelle Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</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>Glioblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03287063
org study id: UMCC 2017.094
secondary id: HUM00134165
nct id: NCT03287063
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be
      non-invasively identified using imaging phenotypes that identify regionally distinct areas of
      tumor with genetic alterations that drive tumor resistance pathways. The researchers propose
      a unique approach to assess initial GBM heterogeneity by performing histological and genomic
      analysis of biopsies targeted by advanced MRI before treatment.
observational model: Cohort
time perspective: Prospective
measure: Identify candidate genes with differential expression in therapy-resistant imaging subvolumes
time frame: At time of surgery
intervention type: Other
intervention name: Tumor Biopsy
description: Stereotactic biopsies will be performed prior to resection.
Specimens will be analyzed with next generation sequencing (NGS). The primary objective is to
      identify candidate genes with differential expression in therapy-resistant imaging
      subvolumes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle Kim, M.D.
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
sharing ipd: Undecided