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

Enrolling by invitation

Conditions studied: Brain Cancer, Lung Cancer (Diagnosis), Renal Cancer

In brief

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.

Key facts

Study ID

NCT07307157

Run by

Harvard Medical School (HMS and HSDM)

People needed

30

Starts

2025-06-12

Expected to finish

2026-01-31

Last updated by the study team

2025-12-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior involvement in the design or validation of the COSMO AI system
• Inability to commit sufficient time to complete assigned case reviews
• Presence of significant financial conflicts of interest related to the study outcomes

Where it is running

• Harvard Medical School — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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