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Идёт набор NCT07677124

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

Наблюдательное Basal Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Basal Cell Carcinoma. Базовые параметры: 0 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Accuracy of artificial intelligence-based classification of basal cell carcinoma risk groups [Срок оценки: Baseline]
Вторичные конечные точки (2)
  • 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 [Срок оценки: baseline]
  • Diagnostic accuracy (accuracy, sensitivity, specificity, F1-score and ROC-AUC) of artificial intelligence compared with dermatologists for basal cell carcinoma risk classification [Срок оценки: baseline]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07677124 · SBU-IEAH-DERM-BCCAI-163 · IEAH-EC-163

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗