Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO) (NCT06038760) | Clinical Trial Compass
TerminatedNot Applicable
Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Stopped: Lack of funding
United Kingdom12 participantsStarted 2023-10-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Able to give written informed consent prior to admission to this study;
✓. Female or male aged ≥18 years;
✓. Patient consents to the use of their surgical sample and 40mL of whole blood for research purposes
✓. Surgical sample and yields ≥0.4g for the study
✓. 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 criteria
✕. Inoperable or biopsy only
✕. Suspected lymphoma or myeloma, or grade 1 meningioma
✕. 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)
✕. Recurrence of cancer originating from a site other than the brain
✕. 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.