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/NCT05978557</url>
    </required_header>
    <id_info>
      <org_study_id>LCCC2212</org_study_id>
      <nct_id>NCT05978557</nct_id>
    </id_info>
    <brief_title>Brain Slice Explants to Predict Drug Response in Brain Tumors</brief_title>
    <official_title>A Feasibility Study to Determine if a Novel Patient-derived Explant Platform Can Produce Drug Sensitivity Scores Within a Clinically Relevant Time Frame in Patients With CNS Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>UNC Lineberger Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>UNC Lineberger Comprehensive 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>
        This biospecimen collection study will evaluate the feasibility of engrafting and testing&#xD;
        resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response,&#xD;
        in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and&#xD;
        unfortunately there are no reliable precision oncology platforms that can identify the most&#xD;
        effective therapy for each patient. Recent work has demonstrated the success of functional&#xD;
        precision oncology platforms using patient-derived explant (PDE) at predicting drug response&#xD;
        in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may&#xD;
        prove effective as functional models for CNS tumors. The purpose of this study is to explore&#xD;
        the feasibility of using a novel PDE platform to generate drug sensitivity scores from&#xD;
        patients with central nervous system tumors in Pediatric and adult subjects having low- or&#xD;
        high-grade CNS tumors resected. The secondary objective is to estimate the proportion of&#xD;
        successfully scaled PDEs generated per given tumor size.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">March 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of specimens yielding scores</measure>
      <time_frame>Up to 28 days</time_frame>
      <description>The proportion of evaluable specimens yielding patient-derived explant (PDE) drug sensitivity scores. Specimens will be collected during surgery for tumor resection. Excised specimens will be processed to generate PDE-based functional drug screening models. A panel of therapeutics will be chosen for each specimen according to pre-set criteria determined.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The scalability of evaluable specimens</measure>
      <time_frame>Up to 28 days</time_frame>
      <description>The percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Central Nervous System Tumor</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biospecimen collection</intervention_name>
      <description>Biospecimen will be collected during surgery.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric and adult subjects having low- or high-grade central nervous system tumors&#xD;
          resected.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          In order to participate in this study a subject must meet all of the eligibility criteria&#xD;
          outlined below.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent obtained to participate in the study and HIPAA authorization&#xD;
               for the release of personal health information or written assent and parental consent&#xD;
               for pediatric subjects or surrogate consent provided by the subject's legally&#xD;
               authorized guardians.&#xD;
  &#xD;
            2. A diagnosis of a tumor residing in the central nervous system with surgery plan to&#xD;
               have surgical resection.&#xD;
  &#xD;
            3. The subject is willing and able to comply with study procedures based on the judgment&#xD;
               of the investigator or protocol designer.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. All subjects must not meet any of the following exclusion criteria prior to enrollment&#xD;
               to participate in this study:&#xD;
  &#xD;
               Any serious medical or psychiatric disorder that would interfere with the subject's&#xD;
               ability to give informed consent.&#xD;
  &#xD;
            2. Incarcerated individuals.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrew B Satterlee, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Devin McCarthy</last_name>
      <phone>919-966-7654</phone>
      <email>devin_mccarthy@med.unc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Luz Cuaboy</last_name>
      <email>luz_cuaboy@med.unc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UNC Lineberger Comprehensive Cancer Center</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27516</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrew B Satterlee, PhD</last_name>
        <email>satterle@email.unc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Devin McCarthy</last_name>
        <email>devin_mccarthy@med.unc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://unclineberger.org/patientcare/clinical-trials/clinical-trials</url>
      <description>University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>patient-derived explant</keyword>
    <keyword>tissue</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nervous System Neoplasms</mesh_term>
      <mesh_term>Central Nervous System 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/NCT05978557
  org study id: LCCC2212
  nct id: NCT05978557
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This biospecimen collection study will evaluate the feasibility of engrafting and testing
        resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response,
        in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and
        unfortunately there are no reliable precision oncology platforms that can identify the most
        effective therapy for each patient. Recent work has demonstrated the success of functional
        precision oncology platforms using patient-derived explant (PDE) at predicting drug response
        in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may
        prove effective as functional models for CNS tumors. The purpose of this study is to explore
        the feasibility of using a novel PDE platform to generate drug sensitivity scores from
        patients with central nervous system tumors in Pediatric and adult subjects having low- or
        high-grade CNS tumors resected. The secondary objective is to estimate the proportion of
        successfully scaled PDEs generated per given tumor size.
  observational model: Cohort
  time perspective: Prospective
  measure: Proportion of specimens yielding scores
  time frame: Up to 28 days
  description: The proportion of evaluable specimens yielding patient-derived explant (PDE) drug sensitivity scores. Specimens will be collected during surgery for tumor resection. Excised specimens will be processed to generate PDE-based functional drug screening models. A panel of therapeutics will be chosen for each specimen according to pre-set criteria determined.
  measure: The scalability of evaluable specimens
  time frame: Up to 28 days
  description: The percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.
  intervention type: Other
  intervention name: Biospecimen collection
  description: Biospecimen will be collected during surgery.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Andrew B Satterlee, PhD
  role: Principal Investigator
  affiliation: UNC Lineberger Comprehensive Cancer Center
  last name: Devin McCarthy
  phone: 919-966-7654
  email: devin_mccarthy@med.unc.edu
  last name: Luz Cuaboy
  email: luz_cuaboy@med.unc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  url: http://unclineberger.org/patientcare/clinical-trials/clinical-trials
  description: University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
  responsible party type: Sponsor
  mesh term: Nervous System Neoplasms
  mesh term: Central Nervous System Neoplasms
  sharing ipd: No