Developing biomarkers and methods of risk stratification: Consensus statements from the International Kidney Cancer...

Accurate prognostication and personalized treatment selection remain major challenges in kidney cancer. This consensus initiative aimed to provide actionable expert guidance on the development and clinical integration of prognostic and predictive biomarkers and risk stratification tools to improve patient care and guide future research. A modified Delphi method was employed to develop consensus statements among a multidisciplinary panel of experts in urologic oncology, medical oncology, radiation oncology, pathology, molecular biology, radiology, outcomes research, biostatistics, industry, and patient advocacy. Over 3 rounds, including an in-person meeting 20 initial statements were evaluated, refined, and voted on. Consensus was defined a priori as a median Likert score ≥8. Nineteen final consensus statements were endorsed. These span key domains including biomarker prioritization (favoring prognostic biomarkers), rigorous methodology for subgroup and predictive analyses, the development of multi-institutional prospective registries, incorporation of biomarkers in trial design, and improvements in data/biospecimen access. The panel also identified high-priority biomarker types (e.g., AI-based image analysis, ctDNA) for future research. This is the first consensus statement specifically focused on biomarker and risk model development for kidney cancer using a structured Delphi process. The recommendations emphasize the need for rigorous methodology, collaborative infrastructure, prospective data collection, and focus on clinically translatable biomarkers. The resulting framework is intended to guide researchers, cooperative groups, and stakeholders in advancing personalized care for patients with kidney cancer.