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

Launched by OUROTECH, INC. · Sep 8, 2023

Keywords

ClinConnect Summary

The PEAR-GLIO clinical trial is studying a new tool developed by Pear Bio that uses a 3D model of a patient's brain tumor to see how it responds to different cancer treatments. This trial is specifically for adults who have been diagnosed with certain types of primary brain tumors, such as gliomas and ependymomas, and are scheduled for surgery. In order to participate, patients must be at least 18 years old, have a tumor that can be surgically removed, and agree to provide a sample of their tumor and some blood for research purposes.

Participants in this trial can expect that their tumor samples will be tested in the lab to understand how well various approved cancer treatments work against their specific tumor. The doctors treating the patients will not know the results of these tests while they are being treated, which helps ensure that the study results are unbiased. The main goal is to see if the treatments work as expected, and researchers will also look at how the test results relate to the patients' actual outcomes. This study is currently recruiting participants and aims to improve how brain tumors are treated in the future.

Gender

ALL

Eligibility criteria

• Inclusion:
• • 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.
• Exclusion:
• • 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.