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CNN-Based AI Versus Physicians for Solitary Skin Lesion Diagnosis

NCT07415291 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 17625

Last updated 2026-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Solitary Skin Lesions
  • Skin Neoplasms
  • Skin Neoplasm Malignant

Sponsors & Collaborators

  • Istanbul Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Ayşe Esra Koku Aksu, MD · Sağlık Bilimleri Üniversitesi İstanbul Eğitim ve Araştırma Hastanesi

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-03-30
Completion
2026-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415291 on ClinicalTrials.gov