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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07677124
Acronym
BCC-AI
Enrollment
2500
Registered
2026-06-30
Start date
2026-05-22
Completion date
2027-05-22
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

Basal Cell Carcinoma, Artificial Intelligence, Convolutional Neural Network, Dermoscopy, Skin Cancer, Histopathological Subtypes, Risk Classification

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Istanbul Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groupsBaselineDiagnostic 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

MeasureTime frameDescription
Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of convolutional neural network for histopathological subtype prediction of basal cell carcinoma using dermoscopic imagesbaselineDiagnostic 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.
Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of artificial intelligence compared with dermatologists for basal cell carcinoma risk classificationbaselineComparison 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTTugce Nur Izbudak Kara, MD
eizbudak@icloud.com+905395976598
PRINCIPAL_INVESTIGATORAyse Esra Koku Aksu, MD

Istanbul Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026