Clinical trial NCT06038760: Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Official title: Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor
Glioma, Malignant
Ependymoma
Oligodendroglioma
Glioblastoma
Keywords: computer vision
cell culture
microtumor
functional testing
predictive biomarker
precision medicine
oncology
brain cancer
Lead sponsor: Ourotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2023-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary solid brain tumor

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.

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.

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.

Primary outcomes:
measure: Differentiated ex vivo treatment response
timeFrame: 2 weeks
Secondary outcomes:
measure: Progression-free survival correlation
timeFrame: 1 year
Other outcomes:
measure: Culture success rate of tumor cells
timeFrame: 1 week
measure: Culture rates success for immune cells
timeFrame: 1 week
measure: Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes
timeFrame: 12 months
measure: Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS
timeFrame: 12 months
measure: Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS
timeFrame: 12 months
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Matt Williams, FRCR PhD
role: PRINCIPAL_INVESTIGATOR
References: