PEAR-MET
Research type
Research Study
Full title
Prospective Evaluation of AI R&D tool for patient stratification - Mechanism of action Evaluation in Triple negative breast cancer (PEAR-MET)
IRAS ID
316023
Contact name
Duleek Ranatunga
Contact email
Sponsor organisation
Ourotech Limited (trading as Pear Bio)
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Triple-negative breast cancer (TNBC) has the worst prognosis of all the breast cancer subtypes. Stage 4 TNBC has a median overall survival of 13.3 months with treatment. However, an increasing number of treatment options are being approved to treat TNBC. With multiple treatment options now available, it is critical for a treating oncologist to use lab tests that can help guide treatment decision making and improve patient outcomes.
Pear Bio (the Sponsor) have developed a diagnostic test that helps oncologists decide on the appropriate course of treatment for patients with TNBC. The diagnostic test uses a small tumour sample taken from the patient, alongside a blood sample. Samples are placed in a device called an organ-on-a-chip, which acts as a proxy for the patient to test treatment options in a laboratory without exposing the actual patient to those treatments. Various approved treatment options are tested in parallel organ-on-a-chips at Pear Bio's central laboratory. A report is generated on which treatments work best on a given patient's tumour sample, so their oncologist can prescribe an effective treatment.
As Pear Bio's technology is still in early development, this study will serve to validate the technology observationally, and will therefore not affect the patients' treatment choices or guide treatment decision-making. Tumour and blood samples are taken from patients during a core needle biopsy or fine needle aspirate procedure and used to optimise Pear Bio's technology to test FDA approved TNBC therapies. This study will enable future studies that are used to guide treatment decisions between multiple approved treatment options on a personalised basis. Outside of sample and data collection, this is a laboratory-based study designed to optimise various aspects of Pear Bio's technology for advanced TNBC, including treatment administration in the organ-on-a-chip.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0229
Date of REC Opinion
13 Oct 2022
REC opinion
Further Information Favourable Opinion