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NCT Number: NCT07677124

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

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.

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Key information

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayse Esra Koku Aksu, MD

CONTACT

[email protected]

+905059126069

Ayse Esra Koku Aksu, MD

PRINCIPAL_INVESTIGATOR

Duygu Yamen, MD

SUB_INVESTIGATOR

Tugce Nur Izbudak Kara, MD

SUB_INVESTIGATOR

tugce nur izbudak kara, MD

CONTACT

[email protected]

+905395976598

About this study

Basal cell carcinoma (BCC) is the most common skin malignancy and comprises histopathological subtypes with different biological behaviors, recurrence risks, and treatment implications. Accurate identification of high-risk and low-risk subtypes is important for clinical decision-making. Dermoscopy improves diagnostic accuracy in BCC; however, prediction of histopathological risk categories based solely on dermoscopic findings remains challenging.

This retrospective observational study will use archived clinical and dermoscopic images, histopathology reports, and clinical records of patients with histopathologically confirmed BCC. All data will be anonymized before analysis. Images containing identifiable patient information will be excluded.

A convolutional neural network (CNN)-based artificial intelligence model will be developed using clinical and dermoscopic images. Images will undergo preprocessing, including standardization of image size, normalization procedures, and removal of potentially identifiable information. The dataset will be divided into training, validation, and test sets while maintaining separation at the patient level to avoid data leakage.

The primary outcome is the diagnostic performance of the CNN model for classification of BCC into low-risk and high-risk histopathological groups. Secondary outcomes include prediction of histopathological subtypes and comparison of model performance with dermatologist assessments. Histopathological diagnosis will serve as the reference standard.

Model performance will be evaluated using accuracy, sensitivity, specificity, precision, recall, F1 score, and area under the receiver operating characteristic curve (ROC-AUC). Comparisons between the artificial intelligence model and physician assessments will be performed using appropriate statistical methods. Interobserver agreement may also be assessed when applicable.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: baseline

    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.

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

    Time frame: baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tugce Nur Izbudak Kara, MD

CONTACT

[email protected]

+905395976598

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Risk Classification and Prediction of Histopathological Subtypes in Basal Cell Carcinoma Using a CNN-Based Artificial Intelligence Model on Dermoscopic Images

Acronym: BCC-AI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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