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

NCT06264479 | Terminated DMC

• 1 other identifier: PEAR-TREE2
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 4

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 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).

Conditions

Kidney Cancer; Renal Cell Cancer Metastatic

Keywords

computer vision; cell culture; microtumor; functional testing; predictive biomarker; immuno-oncology

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate correlation accuracy (sensitivity & specificity)

  The sensitivity, specificity PPV and NPV of Pear image-based biomarkers are established against patient ORR (evaluated on imaging).

  6 months

Secondary Outcomes (4)

• Complete Response rate correlation accuracy (sensitivity & specificity)

  2 years

• Deep Response rate correlation accuracy (sensitivity & specificity)

  2 years

• Durable Response rate correlation accuracy (sensitivity & specificity)

  2 years

• PFS prediction accuracy

  2 years

Other Outcomes (3)

• Culture success rate

  4 days

• Hazard ratio by biomarker group

  2 years

• OS prediction accuracy

  2 years

Study Arms (1)

Trial Cohort

Patients with advanced or metastatic kidney cancer, due to start a new line of systemic therapy (targeted drug, immunotherapy, etc.)

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Patients undergo a biopsy from a lesion, and give 40ml of blood

Trial Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced or metastatic kidney cancer, due to start a new line of therapy

You may qualify if:

• Able to give written informed consent prior to admission to this study.
• Female or male aged ≥18 years.
• Evidence of advanced RCC with intention to receive systemic therapy, defined as:
• Clinical suspicion of advanced RCC with intention to undergo a clinically-mandated biopsy and subsequent systemic therapy OR
• Histological evidence of advanced RCC with intention to undergo subsequent systemic therapy and willing to undergo additional research biopsy
• At least one lesion evaluable under RECIST 1.1 criteria
• Willing to donate at least two additional core biopsy samples prior to starting subsequent systemic therapy.
• Willing to undergo venous sampling for 40mL of blood

You may not qualify if:

• Early stage kidney cancer
• Patients who do not have kidney cancer
• Patients with RCC that do not intend to receive systemic therapy
• Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
• Previous diagnosis of other cancer. Previously treated cancer may be acceptable in some circumstances (e.g. surgery for an unrelated cancer \> 5 years ago) after discussion with the Sponsor.
• No lesions are amenable to biopsy

Sponsors & Collaborators

• Ourotech, Inc.: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• Cambridge University Hospitals NHS Trust: collaborator
• East & North Herts NHS Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (4)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Mount Vernon Cancer Centre

London, HA6 2RN, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Royal Free NHS Foundation Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor cores and blood

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ekaterini Boleti

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: June 19, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)