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

NCT07307157 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-12-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Digital Pathology Evaluation

Digital Pathology Evaluation

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    lead OTHER

Principal Investigators

  • Kun-Hsing Yu, MD, PhD · Harvard Medical School (HMS and HSDM)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307157 on ClinicalTrials.gov