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Enrolling By InvitationNot applicableNCT07307157
Official study title

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

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedDigital Pathology Evaluation

The study team can explain what participation involves.

Who it may be forBrain Cancer · Lung Cancer (Diagnosis)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 29, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Enrolling By Invitation

Participation is limited to people invited by the study team.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Harvard Medical School (HMS and HSDM)

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Harvard Medical School (HMS and HSDM)
Interventions being studied
Diagnostic Test: Digital Pathology Evaluation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Harvard Medical SchoolBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 29, 2025. Always confirm current availability with the study team.

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