Harvard Medical School (HMS and HSDM)
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.
Study Rationale and Background Diagnostic accuracy in cancer subtype classification varies significantly among pathologists due to differences in expertise, experience, and access to diagnostic resources. The emergence of AI systems in pathology offers the potential to enhance diagnostic performance and consistency in cancer classification. However, direct empirical comparisons of AI-based predictions and pathologists' diagnostic performance on identical cases remain limited in the literature. Study Aims This head-to-head comparative study aims to: (1) evaluate the diagnostic performance of t…
Inclusion Criteria: * Board-certified pathologist with expertise in neuropathology, pulmonary pathology, urologic pathology, or general anatomical pathology * Minimum of 3 years of clinical diagnostic experience * Active clinical practice involving diagnostic pathology slide review * Willingness to independently review and diagnose up to 300 de-identified whole-slide images * Ability to access the study platform and complete case reviews within the specified study timeline * Provision of informed consent for study participation Exclusion Criteria: * Prior involvement in the design or valida…
Digital Pathology Evaluation
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