Actively Recruiting
Prospective Evaluation of AI R&D Tool for Patient Stratification - MoA Evaluation in Triple Negative Breast Cancer (PEAR-MET)
Led by Ourotech, Inc. · Updated on 2024-04-03
30
Participants Needed
3
Research Sites
113 weeks
Total Duration
On this page
Sponsors
O
Ourotech, Inc.
Lead Sponsor
G
Guys' and St. Thomas Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pear Bio has developed an organ-on-a-chip device together with a computer vision pipeline through which the response of an individual patient's tumor to different systemic therapy regimens can be tested simultaneously ex vivo. This study will recruit patients with advanced or metastatic triple negative breast cancer who are due to start a clinically-indicated new line of therapy. The oncologist will be blinded to the 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 sensitivity and specificity of Pear Bio's test against patient outcomes (response, progression-free survival, overall survival)
CONDITIONS
Official Title
Prospective Evaluation of AI R&D Tool for Patient Stratification - MoA Evaluation in Triple Negative Breast Cancer (PEAR-MET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent before joining the study
- Female or male aged 18 years or older
- Histologically confirmed primary breast cancer that is triple-negative following ASCO/CAP guidelines
- Stage 4 or locally advanced breast cancer planned for first line systemic therapy, or previously treated and due for another systemic therapy
- Willing and able to undergo a mandatory core needle biopsy (minimum 2 cores) or fine needle aspiration from the breast tumor or metastasis before starting therapy
- Willing and able to give 40 mL of blood for research purposes
You will not qualify if you...
- Tumors not confirmed as triple negative breast cancer
- Early stage triple negative breast cancer
- Patients with triple negative breast cancer who do not plan to receive systemic therapy
- Patients who have started systemic therapy with no plans to change therapy after biopsy or fine needle aspiration
- Patients scheduled to receive experimental therapies not included in the study
- Hemoglobin levels below 80 g/L before research sample collection
- Any other disease, physical condition, or laboratory finding that could affect results interpretation, increase treatment risk, or interfere with informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Not Yet Recruiting
2
Barts Hospital NHS Trust
London, United Kingdom
Actively Recruiting
3
Guys and St. Thomas Hospital NHS Trust
London, United Kingdom
Not Yet Recruiting
Research Team
D
Duleek Ranatunga
CONTACT
E
Elli Tham
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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