NCT06264479

Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Ourotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patient's 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 patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's 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 test's sensitivity, specificity, positive predictive value and negative predictive value.

Conditions

• Kidney Cancer
• Renal Cell Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Patients undergo a biopsy from a lesion, and give 40ml of blood

Timeline

• Start date: 2024-06-19
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2024-02-20
• Last updated: 2025-07-30

Locations

4 sites across 1 country: United Kingdom