What this study is
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.
What's being tested
- Digital Pathology Evaluation
Intervention · DIAGNOSTIC TEST
Digital Pathology Evaluation
Study details
- Sponsor
- Harvard Medical School (HMS and HSDM)
- Conditions
- Brain Cancer · Lung Cancer (Diagnosis) · Renal Cancer
- Enrolling
- 30 people
- Starts
- 2025-06-12
- Est. completion
- 2026-01-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHarvard Medical School
Boston, Massachusetts, United States
Study team
Sponsor
Harvard Medical School (HMS and HSDM)
Study ID Yu Lab COSMO Study
Principal investigator
Kun-Hsing Yu, MD, PhD
Harvard Medical School (HMS and HSDM)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.