AI-Based Risk Classification and Histopathological Subtype Prediction of Basal Cell Carcinoma Using Dermoscopic Images

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-100
SponsorIstanbul Training and Research Hospital

About this trial

This retrospective observational study aims to develop and evaluate a convolutional neural network (CNN)-based artificial intelligence model for risk classification and histopathological subtype prediction of basal cell carcinoma (BCC) using clinical and dermoscopic images. Histopathologically confirmed BCC cases from a dermatology archive will be included. The primary objective is to assess the diagnostic performance of the CNN model in classifying BCC as low-risk or high-risk. Secondary objectives include predicting histopathological subtypes and comparing the model's performance with that of dermatology physicians. Histopathological diagnosis will serve as the reference standard. All archived data will be anonymized before analysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histopathologically confirmed basal cell carcinoma.

Cases with a specified histopathological subtype.

Availability of dermoscopic images with sufficient image quality and resolution for artificial intelligence analysis.

Disqualifiers

Cases without histopathological confirmation of basal cell carcinoma.

Cases with unspecified histopathological subtype.

Images with insufficient quality or resolution for artificial intelligence analysis.

Cases without available dermoscopic images.

Trial population

The study population consists of patients with histopathologically confirmed basal cell carcinoma who have dermoscopic images of sufficient quality for artificial intelligence analysis and documented histopathological subtype information. Archived clinical and dermoscopic images collected at Istanbul Training and Research Hospital will be retrospectively analyzed.

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 2 trial groups
Group A: Low-Risk Basal Cell Carcinoma
Group B: High-Risk Basal Cell Carcinoma

Trial outcomes

Primary outcomes

1

Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groups

Diagnostic accuracy of the convolutional neural network model in distinguishing low-risk and high-risk basal cell carcinoma using dermoscopic images, compared with histopathological diagnosis as the reference standard.

Time frame
Baseline

Secondary outcomes

1

Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of convolutional neural network for histopathological subtype prediction of basal cell carcinoma using dermoscopic images

Diagnostic performance of the convolutional neural network in predicting histopathological subtypes of basal cell carcinoma from dermoscopic images compared with histopathological diagnosis (reference standard). Diagnostic accuracy will be assessed using accuracy, sensitivity, specificity, precision, F1-score and ROC-AUC.

Time frame
baseline
2

Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of artificial intelligence compared with dermatologists for basal cell carcinoma risk classification

Comparison of diagnostic performance between the artificial intelligence model and dermatologists in risk classification of basal cell carcinoma. Performance will be assessed using accuracy, sensitivity, specificity, precision, F1-score and ROC-AUC.

Time frame
baseline

Other outcomes

Sponsors and contacts

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