protocolSection identificationModule nctId: NCT06264479, orgStudyIdInfo id: PEAR-TREE2, briefTitle: Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2, acronym: PEAR-TREE2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ourotech, Inc., class: INDUSTRY, collaborators name: Royal Free Hospital NHS Foundation Trust, collaborators name: Cambridge University Hospitals NHS Trust, collaborators name: East & North Herts NHS Trust, collaborators name: Imperial College Healthcare NHS Trust, descriptionModule briefSummary: 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)., conditionsModule conditions: Kidney Cancer, conditions: Renal Cell Cancer Metastatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, outcomesModule primaryOutcomes measure: Objective Response Rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: Complete Response rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: Deep Response rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: Durable Response rate correlation accuracy (sensitivity & specificity), secondaryOutcomes measure: PFS prediction accuracy, otherOutcomes measure: Culture success rate, otherOutcomes measure: Hazard ratio by biomarker group, otherOutcomes measure: OS prediction accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Addenbrooke's Hospital, city: Cambridge, state: Cambridgeshire, zip: CB2 0QQ, country: United Kingdom, contacts name: Kate Fife, role: CONTACT, geoPoint lat: 52.2, lon: 0.11667, locations facility: Mount Vernon Cancer Centre, city: London, zip: HA6 2RN, country: United Kingdom, contacts name: Anand Sharma, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, zip: W6 8RF, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Free NHS Foundation Trust, city: London, country: United Kingdom, contacts name: Ekaterini Boleti, MD PhD MRCP, role: CONTACT, phone: 020 7830 2396, phoneExt: 34476, geoPoint lat: 51.50853, lon: -0.12574, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-28, uploadDate: 2023-07-28T07:18, filename: Prot_SAP_000.pdf, size: 424039, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-28, uploadDate: 2023-07-28T07:19, filename: ICF_001.pdf, size: 197013, hasResults: False