NCT07307157Enrolling by invitation
Head-to-Head Evaluation of the Cancer Ontology Supervised Multimodal Orchestration (COSMO) AI System Versus Pathologist-Only Review
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 13 Dec 2025
- Start date
- 12 Jun 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Diseases
- Kidney cancer, Lung cancer, Childhood cancers
- NCT number
- NCT07307157
What you commit to
- Study type: Observational
- Planned participants: 30
- From 12 Jun 2025 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior involvement in the design or validation of the COSMO AI system
Other
- Inability to commit sufficient time to complete assigned case reviews
- Presence of significant financial conflicts of interest related to the study outcomes
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harvard Medical School Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.