Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038760
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-09-08
Brief Title:
Prospective Evaluation of AI RD Tool in Adult Glioma and Other Primary Brain Tumours PEAR-GLIO
Sponsor:
Ourotech Inc
Organization:
Ourotech Inc
Study Overview
Official Title:
Prospective Evaluation of AI RD Tool in Adult Glioma and Other Primary Brain Tumours PEAR-GLIO
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAR-GLIO
Brief Summary:
Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patients 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 patients 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
Oncologists will be blinded to treatment response on the Pear Bio tool the assay will be run in parallel with the patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None