Clinical trial · Observational
Head-to-Head Evaluation of the Cancer Ontology Supervised Multimodal Orchestration (COSMO) AI System Versus Pathologist-Only Review
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Renal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Pathology Evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- AI-Based Evaluation using COSMO
- label
- Pathologist-Based Evaluation
- interventionNames
- Diagnostic Test: Digital Pathology Evaluation
Primary outcomes (1)
- measure
- Diagnostic performance
- timeFrame
- Periprocedural (at the time of slide review)
- description
- Diagnostic performance of the COSMO AI system and pathologists in identifying cancer subtypes across brain, lung, and kidney tumors, as assessed by accuracy, balanced accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUROC). We will include both overall comparisons and stratified evaluations by anatomical site and cancer incidence category (common vs. rare or uncommon).
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 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
References
Publications (0)
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