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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06038760
Other study ID # PEAR-GLIO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 12, 2023
Est. completion date December 1, 2025

Study information

Verified date December 2023
Source Ourotech, Inc.
Contact Duleek Ranatunga
Phone +44 7716558079
Email duleek@pearbio.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (2)

Lead Sponsor Collaborator
Ourotech, Inc. Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Culture success rate of tumor cells 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. 1 week
Other Culture rates success for immune cells 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. 1 week
Other Find correlations between ex vivo tumor culture or multi-omic biomarkers and real-world patient outcomes To correlate Pear assay results, biomarkers and outcomes 12 months
Other Assess Pear Bio's assay ability to categorise patients for below average or above average overall survival (OS Categorisation of patients into survival cohorts using the Pear assay 12 months
Other Assess the correlation of omics biomarkers to patient PFS, ORR and/or OS Correlation between biomarkers and clinically relevant outcomes 12 months
Primary Differentiated ex vivo treatment response Measurement of treatment response in the Pear Assay 2 weeks
Secondary Progression-free survival correlation The correlation between response in the Pear Bio system and PFS in patients 1 year
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