跳至主要内容
临床试验/NCT07786376
NCT07786376尚未招募不适用

Evaluation of Artificial Intelligence Algorithms Performance in the Histopathological Diagnosis of Basal Cell Carcinoma

Al-Azhar University0 个研究点目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
the diagnostic accuracy of the artificial intelligence algorithm, evaluated primarily by its sensitivity and specificity in correctly identifying basal cell carcinoma (BCC) from histopathological images.

研究概览

简要总结

The goal of this study is to evaluate the diagnostic performance of an Artificial Intelligence (AI) algorithm in the histopathological diagnosis of bcc compared to certified dermatopathologists

详细描述

Background Basal cell carcinoma (BCC) is the most commonly diagnosed skin cancer worldwide and the predominant form of non-melanoma skin cancers (NMSCs), with an escalating global incidence. Histopathology remains the gold standard for diagnosis; however, manual analysis is labor-intensive, time-consuming, and subject to increasing pressure amid a global shortage of board-certified dermatopathologists. Digital pathology and whole-slide imaging (WSI), combined with advanced artificial intelligence (AI) models such as vision transformers and large language models (e.g., HistoGPT), offer a transformative solution to automate and streamline dermatopathological diagnostics.

Aim of the Work This study aims to evaluate the diagnostic performance and processing efficiency of the AI algorithm HistoGPT in the histopathological diagnosis of basal cell carcinoma compared to certified dermatopathologists.

Methodology This retrospective, blinded, comparative study will be conducted using archived H&E-stained glass slides retrieved from the pathology archive of the Al-Hussein Dermatopathology Unit between 2010 and 2019. Slides meeting the inclusion criteria will be digitized into high-resolution Whole Slide Images (WSIs) at 40× magnification using the Leica Aperio GT450 scanner. The digitized WSIs will be processed and analyzed through the HistoGPT cloud platform to automatically generate diagnostic reports and classifications. The AI-generated findings will be systematically compared against the reference standard diagnoses established by a panel of certified dermatopathologists under the supervision of Prof. Hussein Hasb El-Nabi. Diagnostic accuracy, concordance, and turnaround time will be evaluated.

Statistical Analysis Data will be analyzed using SPSS (version 26.0) or R-programming. Categorical variables will be compared using appropriate statistical tests, and a $p$-value of $< 0.05$ will be considered statistically significant.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Histopathological slides diagnosed as BCC.
  • Slides with adequate staining and preservation allowing clear visualization of dermatopathological features.

排除标准

  • Slides with poor staining quality or significant artifacts interfering with histopathological interpretation.
  • Slides that were damaged, faded, or inadequately preserved.
  • Cases with uncertain or inconclusive original diagnoses.
  • Slides that could not be successfully digitized due to technical limitations ex very short or too long slides.

结局指标

主要结局

the diagnostic accuracy of the artificial intelligence algorithm, evaluated primarily by its sensitivity and specificity in correctly identifying basal cell carcinoma (BCC) from histopathological images.

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaa Hamada Abdu

dermatology specialist

Al-Azhar University

相似试验