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

Inclusion Criteria

• •Inclusion:
• •1. Able to give written informed consent prior to admission to this study.
• •2. Female or male aged ≥18 years.
• •3. 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
• •4. At least one lesion evaluable under RECIST 1.1 criteria
• •5. Willing to donate at least two additional core biopsy samples prior to starting subsequent systemic therapy.
• •6. Willing to undergo venous sampling for 40mL of blood
• •Exclusion:
• •1. Early stage kidney cancer
• •2. Patients who do not have kidney cancer
• •3. Patients with RCC that do not intend to receive systemic therapy
• •4. Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy.
• •5. 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.
• •6. 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.
• •7. No lesions are amenable to biopsy