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

• ClinicalTrials.gov Identifier: NCT06038760
• Recruitment Status: Recruiting
• First Posted: September 15, 2023
• Last Update Posted: December 27, 2023
• Sponsor: Ourotech, Inc.
• Collaborator: Imperial College Healthcare NHS Trust
• Information provided by (Responsible Party): Ourotech, Inc.

Tracking Information

• First Submitted Date: September 8, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: December 27, 2023
• Actual Study Start Date: October 12, 2023
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 8, 2023)

Differentiated ex vivo treatment response [ Time Frame: 2 weeks ]

Measurement of treatment response in the Pear Assay

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2023)

Progression-free survival correlation [ Time Frame: 1 year ]

The correlation between response in the Pear Bio system and PFS in patients

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 8, 2023)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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)

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Tumor resections and blood

• Sampling Method: Non-Probability Sample
• Study Population: Patients with primary solid brain tumor

Condition

• Brain Tumor
• Glioma, Malignant
• Ependymoma
• Oligodendroglioma
• Glioblastoma

Intervention

Procedure: Resection

Patients undergo a resection from a lesion, and give 40mL of blood

Study Groups/Cohorts

Trial Cohort

Patients with a solid primary brain tumor due to undergo surgery as standard of care

Intervention: Procedure: Resection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 8, 2023): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2025
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Duleek Ranatunga; +44 7716558079; duleek@pearbio.com

Contact: Elli Tham; elli.tham@pearbio.com

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT06038760
• Other Study ID Numbers: PEAR-GLIO
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: Ourotech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Ourotech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Imperial College Healthcare NHS Trust

Investigators

• Principal Investigator: Matt Williams, FRCR PhD; Imperial College London

• PRS Account: Ourotech, Inc.
• Verification Date: December 2023