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/NCT06038760</url>
    </required_header>
    <id_info>
      <org_study_id>PEAR-GLIO</org_study_id>
      <nct_id>NCT06038760</nct_id>
    </id_info>
    <brief_title>Prospective Evaluation of AI R&amp;D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)</brief_title>
    <acronym>PEAR-GLIO</acronym>
    <official_title>Prospective Evaluation of AI R&amp;D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ourotech, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Imperial College Healthcare NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ourotech, Inc.</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>
        Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the&#xD;
        response of an individual patient's tumor to different anti-cancer regimens can be tested&#xD;
        simultaneously ex vivo. This study will recruit patients with primary brain tumors who are&#xD;
        due to undergo surgery.&#xD;
  &#xD;
        Oncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run&#xD;
        in parallel with the patient's treatment). The primary objective of this study is to&#xD;
        establish the ex vivo model and confirm whether approved therapies exhibit their intended&#xD;
        mechanism of action in the model. Secondary objectives include correlating test results to&#xD;
        patient outcomes, where available.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter, observational pilot study that aims to determine the feasibility of&#xD;
        using the Pear Bio tool in patients with primary solid brain tumors.&#xD;
  &#xD;
        Patients who are due to undergo clinically-mandated surgery will provide informed consent to&#xD;
        donate excess tissue and a 40mL blood sample.&#xD;
  &#xD;
        The samples will be tested on the Pear Bio tool while the patient receives their standard of&#xD;
        care treatment. As such, for this study, the result from the Pear Bio tool will not be used&#xD;
        to inform the choice of treatment and the treating oncologist will be blinded to the assay&#xD;
        results.&#xD;
  &#xD;
        We will examine drug mechanism of action (MoA), differentiated response, and correlate that&#xD;
        with outcomes seen in the patients treated in routine clinical practice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</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>Differentiated ex vivo treatment response</measure>
      <time_frame>2 weeks</time_frame>
      <description>Measurement of treatment response in the Pear Assay</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival correlation</measure>
      <time_frame>1 year</time_frame>
      <description>The correlation between response in the Pear Bio system and PFS in patients</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Culture success rate of tumor cells</measure>
      <time_frame>1 week</time_frame>
      <description>The percentage of cultures in which ≥70% of viable tumor cells encapsulated post-isolation on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of tumor samples successfully accepted at the study central lab.</description>
    </other_outcome>
    <other_outcome>
      <measure>Culture rates success for immune cells</measure>
      <time_frame>1 week</time_frame>
      <description>The percentage of cultures in which ≥70% of viable immune cells plated post-extraction on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of blood samples successfully accepted at the study central lab.</description>
    </other_outcome>
    <other_outcome>
      <measure>Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes</measure>
      <time_frame>12 months</time_frame>
      <description>To correlate Pear assay results, biomarkers and outcomes</description>
    </other_outcome>
    <other_outcome>
      <measure>Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS</measure>
      <time_frame>12 months</time_frame>
      <description>Categorisation of patients into survival cohorts using the Pear assay</description>
    </other_outcome>
    <other_outcome>
      <measure>Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS</measure>
      <time_frame>12 months</time_frame>
      <description>Correlation between biomarkers and clinically relevant outcomes</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Brain Tumor</condition>
    <condition>Glioma, Malignant</condition>
    <condition>Ependymoma</condition>
    <condition>Oligodendroglioma</condition>
    <condition>Glioblastoma</condition>
    <arm_group>
      <arm_group_label>Trial Cohort</arm_group_label>
      <description>Patients with a solid primary brain tumor due to undergo surgery as standard of care</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Resection</intervention_name>
      <description>Patients undergo a resection from a lesion, and give 40mL of blood</description>
      <arm_group_label>Trial Cohort</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Tumor resections and blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with primary solid brain tumor&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            1. Patient diagnosed with operable brain cancer, thought likely to be primary solid brain&#xD;
               tumor on imaging (grade 2 - 3 meningioma; grade 1 - 4 tumors otherwise) or with&#xD;
               histologically proven primary malignant solid brain tumor&#xD;
  &#xD;
            2. Able to give written informed consent prior to admission to this study;&#xD;
  &#xD;
            3. Female or male aged ≥18 years;&#xD;
  &#xD;
            4. Patient consents to the use of their surgical sample and 40mL of whole blood for&#xD;
               research purposes&#xD;
  &#xD;
            5. Surgical sample and yields ≥0.4g for the study&#xD;
  &#xD;
            6. Patient consents to providing histopathology data (e.g., confirmation of histological&#xD;
               subtype as oligodendroglioma) and other pseudonymised health information including&#xD;
               imaging, treatment and outcome data.&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            1. Inoperable or biopsy only&#xD;
  &#xD;
            2. Suspected lymphoma or myeloma, or grade 1 meningioma&#xD;
  &#xD;
            3. Preoperative haemoglobin levels below 120g/L&#xD;
  &#xD;
            4. Patients who have already received chemotherapy, targeted therapy, immunotherapy, or&#xD;
               radiotherapy less than 30 days before date of surgery, unless as part of a clinical&#xD;
               trial (requires per-patient sponsor approval)&#xD;
  &#xD;
            5. Recurrence of cancer originating from a site other than the brain&#xD;
  &#xD;
            6. Any other disease, metabolic dysfunction, physical examination finding, or clinical&#xD;
               laboratory finding that, in the investigator's opinion, gives reasonable suspicion of&#xD;
               a disease or condition that may affect the interpretation of the results, render the&#xD;
               patient at high risk from treatment complications or interferes with obtaining&#xD;
               informed consent.&#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>Matt Williams, FRCR PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Duleek Ranatunga</last_name>
      <phone>+44 7716558079</phone>
      <email>duleek@pearbio.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elli Tham</last_name>
      <email>elli.tham@pearbio.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Imperial College Healthcare NHS Trust</name>
        <address>
          <city>London</city>
          <zip>W6 8RF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Waqar Saleem, MRCP FRCR</last_name>
        <phone>020 3311 8427</phone>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>computer vision</keyword>
    <keyword>cell culture</keyword>
    <keyword>microtumor</keyword>
    <keyword>functional testing</keyword>
    <keyword>predictive biomarker</keyword>
    <keyword>precision medicine</keyword>
    <keyword>oncology</keyword>
    <keyword>brain cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioblastoma</mesh_term>
      <mesh_term>Glioma</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
      <mesh_term>Ependymoma</mesh_term>
      <mesh_term>Oligodendroglioma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.</ipd_description>
    </patient_data>
    <study_docs>
      <study_doc>
        <doc_type>Study Protocol</doc_type>
        <doc_url>https://www.pearbio.com/pearglio</doc_url>
      </study_doc>
    </study_docs>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>March 3, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT06038760/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06038760
  org study id: PEAR-GLIO
  nct id: NCT06038760
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the
        response of an individual patient's tumor to different anti-cancer regimens can be tested
        simultaneously ex vivo. This study will recruit patients with primary brain tumors who are
        due to undergo surgery.
  
        Oncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run
        in parallel with the patient's treatment). The primary objective of this study is to
        establish the ex vivo model and confirm whether approved therapies exhibit their intended
        mechanism of action in the model. Secondary objectives include correlating test results to
        patient outcomes, where available.
  This is a multicenter, observational pilot study that aims to determine the feasibility of
        using the Pear Bio tool in patients with primary solid brain tumors.
  
        Patients who are due to undergo clinically-mandated surgery will provide informed consent to
        donate excess tissue and a 40mL blood sample.
  
        The samples will be tested on the Pear Bio tool while the patient receives their standard of
        care treatment. As such, for this study, the result from the Pear Bio tool will not be used
        to inform the choice of treatment and the treating oncologist will be blinded to the assay
        results.
  
        We will examine drug mechanism of action (MoA), differentiated response, and correlate that
        with outcomes seen in the patients treated in routine clinical practice.
  observational model: Cohort
  time perspective: Prospective
  measure: Differentiated ex vivo treatment response
  time frame: 2 weeks
  description: Measurement of treatment response in the Pear Assay
  measure: Progression-free survival correlation
  time frame: 1 year
  description: The correlation between response in the Pear Bio system and PFS in patients
  measure: Culture success rate of tumor cells
  time frame: 1 week
  description: The percentage of cultures in which ≥70% of viable tumor cells encapsulated post-isolation on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of tumor samples successfully accepted at the study central lab.
  measure: Culture rates success for immune cells
  time frame: 1 week
  description: The percentage of cultures in which ≥70% of viable immune cells plated post-extraction on day 0 are still alive on day 3 in the control cultures (no treatment) compared to the number of blood samples successfully accepted at the study central lab.
  measure: Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes
  time frame: 12 months
  description: To correlate Pear assay results, biomarkers and outcomes
  measure: Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS
  time frame: 12 months
  description: Categorisation of patients into survival cohorts using the Pear assay
  measure: Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS
  time frame: 12 months
  description: Correlation between biomarkers and clinically relevant outcomes
  arm group label: Trial Cohort
  description: Patients with a solid primary brain tumor due to undergo surgery as standard of care
  intervention type: Procedure
  intervention name: Resection
  description: Patients undergo a resection from a lesion, and give 40mL of blood
  arm group label: Trial Cohort
  Tumor resections and blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Matt Williams, FRCR PhD
  role: Principal Investigator
  affiliation: Imperial College London
  last name: Duleek Ranatunga
  phone: +44 7716558079
  email: duleek@pearbio.com
  last name: Elli Tham
  email: elli.tham@pearbio.com
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Glioblastoma
  mesh term: Glioma
  mesh term: Brain Neoplasms
  mesh term: Ependymoma
  mesh term: Oligodendroglioma
  sharing ipd: No
  ipd description: Pseudonymised data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
  study doc: 
  provided document: 