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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:
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:
This study is a retrospective, observational diagnostic accuracy study designed to evaluate the performance of a convolutional neural network (CNN)-based artificial intelligence model in the assessment of solitary skin lesions using macroscopic clinical images.
Macroscopic clinical images of solitary skin lesions with histopathological or clinically confirmed diagnoses will be retrospectively retrieved from the dermatology image archive of Istanbul Training and Research Hospital. All images and associated clinical documents will be anonymized prior to analysis, and any identifying visual or textual information will be removed. Data processing and analysis will be conducted in a secure, institution-based environment with restricted access limited to the study team.
A CNN-based artificial intelligence model will be developed using supervised learning techniques. Image preprocessing steps will include resizing to standardized input dimensions, color normalization, and removal of regions containing potentially identifiable information. The dataset will be partitioned into training, validation, and test subsets to enable model development, hyperparameter optimization, and independent performance evaluation. Model training and evaluation will be implemented using the PyTorch deep learning framework.
The diagnostic performance of the CNN-based model will be evaluated using standard classification metrics and will be compared with the independent assessments of dermatologists, dermatology residents, and non-dermatologist physicians who evaluate the same set of anonymized images without access to additional clinical or histopathological information. Comparative analyses will be performed to assess differences in diagnostic performance and agreement between the artificial intelligence model and physician groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Development and Validation Cohort | "This is a single-arm retrospective study consisting of 17,625 archived clinical records with confirmed histopathological diagnoses. The cohort will serve as the primary dataset for AI model development. A specific subset of the test dataset will be independently evaluated by a panel of dermatologists and non-dermatologist physicians through a multiple-choice diagnostic task. The AI model's performance will be compared against both the gold-standard histopathological results and the diagnostic accuracy of the human observers." |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the CNN-based artificial intelligence model | The diagnostic accuracy of the convolutional neural network (CNN)-based artificial intelligence model in the diagnosis of solitary skin lesions will be evaluated using accuracy and area under the receiver operating characteristic curve (ROC-AUC) values based on macroscopic clinical images. | Baseline (Retrospective data analysis will be completed within 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in diagnostic performance between the CNN-based model and dermatologists | The difference in diagnostic performance between the CNN-based artificial intelligence model and dermatologists will be evaluated based on accuracy metrics using the same set of macroscopic clinical images. | Baseline (Expected completion within 5 months) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of licensed physicians, including dermatologists, dermatology residents, and non-dermatologist physicians, who independently evaluate anonymized macroscopic clinical images of solitary skin lesions for diagnostic assessment.
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| Name | Affiliation | Role |
|---|---|---|
| Ayşe Esra Koku Aksu, MD | Sağlık Bilimleri Üniversitesi İstanbul Eğitim ve Araştırma Hastanesi | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.B.Ü. İstanbul Eğitim ve Araştırma Hastanesi | Istanbul | Fatih | 34098 | Turkey (Türkiye) |
Individual participant data will not be shared due to institutional data protection policies and the use of retrospectively collected, anonymized clinical images. Data are stored in a secure institutional environment and are accessible only to the study team.
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Difference in diagnostic performance between the CNN-based model and non-dermatologist physicians |
The difference in diagnostic performance between the CNN-based artificial intelligence model and non-dermatologist physicians will be evaluated based on accuracy metrics using the same image set. |
| Baseline (Expected completion within 5 months) |
| Sensitivity, specificity of the CNN-based model and physician groups | Sensitivity, specificity of the CNN-based artificial intelligence model and physician groups will be calculated and compared in the evaluation of solitary skin lesions. | Baseline (Expected completion within 5 months) |
| F1-score of the CNN-based model and physician groups | F1-score values of the CNN-based artificial intelligence model and physician groups will be calculated and compared in the evaluation of solitary skin lesions. | Baseline (Expected completion within 5 months) |