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Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO) (PEAR-GLIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06038760
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : December 27, 2023
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Ourotech, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment
Brain Tumor Glioma, Malignant Ependymoma Oligodendroglioma Glioblastoma Procedure: Resection

Detailed Description:

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.

The investigators will examine drug mechanism of action (MoA), differentiated response, and correlate that with outcomes seen in the patients treated in routine clinical practice.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Actual Study Start Date : October 12, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2025

Group/Cohort Intervention/treatment
Trial Cohort
Patients with a solid primary brain tumor due to undergo surgery as standard of care
Procedure: Resection
Patients undergo a resection from a lesion, and give 40mL of blood

Primary Outcome Measures :
  1. Differentiated ex vivo treatment response [ Time Frame: 2 weeks ]
    Measurement of treatment response in the Pear Assay

Secondary Outcome Measures :
  1. Progression-free survival correlation [ Time Frame: 1 year ]
    The correlation between response in the Pear Bio system and PFS in patients

Other Outcome Measures:
  1. Culture success rate of tumor cells [ Time Frame: 1 week ]
    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.

  2. Culture rates success for immune cells [ Time Frame: 1 week ]
    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.

  3. Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes [ Time Frame: 12 months ]
    To correlate Pear assay results, biomarkers and outcomes

  4. Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS [ Time Frame: 12 months ]
    Categorisation of patients into survival cohorts using the Pear assay

  5. Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS [ Time Frame: 12 months ]
    Correlation between biomarkers and clinically relevant outcomes

Biospecimen Retention:   Samples With DNA
Tumor resections and blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary solid brain tumor


  1. Patient diagnosed with operable brain cancer, thought likely to be primary solid brain tumor on imaging (grade 2 - 3 meningioma; grade 1 - 4 tumors otherwise) or with histologically proven primary malignant solid brain tumor
  2. Able to give written informed consent prior to admission to this study;
  3. Female or male aged ≥18 years;
  4. Patient consents to the use of their surgical sample and 40mL of whole blood for research purposes
  5. Surgical sample and yields ≥0.4g for the study
  6. Patient consents to providing histopathology data (e.g., confirmation of histological subtype as oligodendroglioma) and other pseudonymised health information including imaging, treatment and outcome data.


  1. Inoperable or biopsy only
  2. Suspected lymphoma or myeloma, or grade 1 meningioma
  3. Preoperative haemoglobin levels below 120g/L
  4. Patients who have already received chemotherapy, targeted therapy, immunotherapy, or radiotherapy less than 30 days before date of surgery, unless as part of a clinical trial (requires per-patient sponsor approval)
  5. Recurrence of cancer originating from a site other than the brain
  6. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06038760

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Contact: Duleek Ranatunga +44 7716558079
Contact: Elli Tham

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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Contact: Waqar Saleem, MRCP FRCR    020 3311 8427      
Sponsors and Collaborators
Ourotech, Inc.
Imperial College Healthcare NHS Trust
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Principal Investigator: Matt Williams, FRCR PhD Imperial College London
  Study Documents (Full-Text)

Documents provided by Ourotech, Inc.:
Study Data/Documents: Study Protocol  This link exits the site

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Responsible Party: Ourotech, Inc. Identifier: NCT06038760    
Other Study ID Numbers: PEAR-GLIO
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: December 27, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ourotech, Inc.:
computer vision
cell culture
functional testing
predictive biomarker
precision medicine
brain cancer
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases