Head-to-Head Evaluation of the Cancer Ontology Supervised Multimodal Orchestration (COSMO) AI System Versus Pathologist-Only Review

This study evaluates the diagnostic performance of the Cancer Ontology Supervised Multimodal Orchestration (COSMO) AI system for cancer subtype classification and compares it head-to-head with pathologist-only review. Pathologists will independently review de-identified whole-slide images derived from up to 300 patients across three anatomical sites (brain, lung, kidney) and provide diagnostic assessments. In parallel, COSMO will process the same cases offline to generate independent predictions, enabling direct comparison of diagnostic accuracy between human experts and the AI system. The study will characterize the diagnostic accuracy of COSMO and pathologists, inter-observer agreement, and variations in performance across anatomical sites and cancer types with different incidence rates. Results will establish how COSMO compares to pathologists on identical cases and will inform the development of AI-assisted diagnostic systems in clinical practice.

NCT Number	NCT07307157
Lead Sponsor	Harvard Medical School (HMS and HSDM)
Conditions	Brain Cancer, Lung Cancer (Diagnosis), Renal Cancer
Enrollment	30 participants
Start Date	2025-06-12
Primary Completion	2026-01-31 (estimated)
Study Completion	2026-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-29