跳至主要内容
临床试验/NCT07677124
NCT07677124招募中不适用

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

Istanbul Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2026年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
1
主要终点
Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tugce Nur Izbudak Kara

MD

Istanbul Training and Research Hospital

研究点 (1)

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