Clinical Trial

AI-Augmented Diagnostic Assessment With ENLIGHT Versus Independent Pathologist Review

Study acronym: ENLIGHT
Enrolling by Invitation
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Summary
This study will evaluate whether artificial intelligence (AI) can enhance clinicians' accuracy, efficiency, and confidence in distinguishing lung adenocarcinoma (LUAD) from lung squamous cell carcinoma (LUSC) and kidney renal papillary cell carcinoma (KIRP) from kidney renal clear cell carcinoma (KIRC) using digitized pathology slides. These subtype classifications are routinely performed by pathologists but can be challenging and time-consuming, particularly in difficult cases. During the study, participating clinicians will review lung and kidney pathology slides under three different conditions: * Unaided Review: Diagnosis without AI assistance. * AI as Double-Check: The clinician first makes an independent diagnosis, after which the AI-generated diagnosis (prediction only or prediction with explanation) is revealed for review. * AI as First-Look: The AI-generated diagnosis (prediction only or prediction with explanation) is presented before the clinician begins the review. Clinicians will be randomly assigned to different review sequences to minimize potential order effects. This study design will enable us to assess the impact of AI assistance on diagnostic accuracy, interpretation time, and clinician confidence.
Trial Details
NCT Number NCT07741058
Lead Sponsor Harvard Medical School (HMS and HSDM)
Conditions Cancer
Enrollment 25 participants
Start Date 2026-07
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-03