A modified Delphi consensus process among 46 multidisciplinary experts evaluated best practices for clinical trial design and therapeutic development across rare non-clear cell RCC subtypes (papillary, chromophobe, MiT family/translocation, collecting duct, renal medullary carcinoma, and fumarate hydratase-deficient RCC), culminating in an in-person meeting on November 13, 2025.
Twenty consensus statements (median Likert score ≥8/10) were endorsed across 5 domains: trial design and endpoints, perioperative trials, operations and accrual, biology-driven/histology-molecular strategy trials, and preclinical efforts — recommending histology-specific designs over pooled 'non-clear cell' approaches and innovative adaptive/single-arm designs for ultra-rare subtypes.
Consensus statements reflect expert opinion rather than prospective data; the panel, while multidisciplinary, may not represent all global perspectives; recommendations are not validated against clinical outcomes.
Avoid lumping rare RCC subtypes into generic 'non-clear cell' trials — design histology-specific and mechanism-informed studies instead. Leverage patient advocacy groups and natural history registries to improve accrual for ultra-rare variants.
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