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CNN-Based AI Versus Physicians for Solitary Skin Lesion Diagnosis

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2026 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv2
  2. Minor Study First Submitted
The goal of this observational study is to evaluate the diagnostic accuracy of a CNN-based artificial intelligence model in patients with solitary skin lesions. The main questions it aims to answer are: * What is the diagnostic performance (sensitivity and specificity) of the CNN-based model in identifying solitary skin lesions using macroscopic clinical images? * How does the diagnostic accuracy of the CNN-based model compare with the evaluations performed by dermatologists and non-dermatologist physicians? Researchers will compare the AI model's diagnostic outputs to the independent evaluations of dermatologists and non-dermatologist physicians to see if the AI model can achieve a diagnostic performance comparable to or better than human clinicians. Participants (physicians acting as clinical readers) will: * Independently review a predefined set of anonymized macroscopic clinical images sourced from a retrospective patient archive. * Provide a primary diagnosis for each lesion based solely on the images, without access to patient history or histopathological results. * Submit their assessments to be compared against the gold standard (histopathological diagnosis) and the AI model's results.
Trial Details
NCT Number NCT07415291
Lead Sponsor Istanbul Training and Research Hospital
Conditions
(from sponsor)
Solitary Skin Lesions, Skin Neoplasms, Skin Neoplasm Malignant
Related terms Skin Neoplasms
Enrollment 17,625 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov