Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264479
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-09
Brief Title:
Prospective Evaluation of AI RD Tool for Patient Stratification a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
Sponsor:
Ourotech Inc
Organization:
Ourotech Inc
Study Overview
Official Title:
Prospective Evaluation of AI RD Tool for Patient Stratification a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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-TREE2
Brief Summary:
Pear Bio has developed a predictive biomarker technology that combines 3D cell culture microscopy and computer vision to measure the response of an individual patients tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo
This study will recruit patients with advanced or metastatic kidney 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 test the test will be run in parallel with the patients treatment The primary objective of this study is to establish the sensitivity and specificity of Pear Bios test results against patient outcomes objective response progression-free survival depth and duration of response overall survival
This study will recruit patients with advanced or metastatic kidney 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 test the test will be run in parallel with the patients treatment The primary objective of this study is to establish the sensitivity and specificity of Pear Bios test results against patient outcomes objective response progression-free survival depth and duration of response overall survival
Detailed Description:
This is a multicenter international observational pilot study that aims to determine the accuracy of a new assay the Pear Bio test in predicting response rate ORR in patients receiving standard of care systemic therapies for kidney cancer Patients will undergo an additional mandatory core needle biopsy of a lesion before commencing their next line of therapy 40mL of blood will also be collected from each patient
The biopsy sample will be run on the Pear Bio test while the patient receives their standard of care treatment As such for this study the result from the Pear Bio test will not be used to inform the choice of treatment and the treating oncologist will be blinded to the test results
The investigators will measure objective response rate ORR and other outcome metrics PFS DoR OS etc The Pear Bio test results will be compared to the actual patient outcomes to determine the tests sensitivity specificity positive predictive value and negative predictive value
The biopsy sample will be run on the Pear Bio test while the patient receives their standard of care treatment As such for this study the result from the Pear Bio test will not be used to inform the choice of treatment and the treating oncologist will be blinded to the test results
The investigators will measure objective response rate ORR and other outcome metrics PFS DoR OS etc The Pear Bio test results will be compared to the actual patient outcomes to determine the tests sensitivity specificity positive predictive value and negative predictive value
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