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NCT Number: NCT07786376

AI in Histipathological Diagnosis of Bcc

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Al hussein universty hospital

Cairo, Nasr City, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: one year

Study contacts

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

wafaa hamada abdu, master

CONTACT

[email protected]

+20 1061583899 ext. +20 1014494376

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: AI\bcc

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 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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