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AI in Histipathological Diagnosis of Bcc

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07786376
Acronym
AI\bcc
Enrollment
50
Registered
2026-08-26
Start date
2026-10-01
Completion date
2027-12-01
Last updated
2026-08-26

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

Conditions

Basal Cell Cancer

Keywords

AI-bcc-histopathology

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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.one year

Countries

Egypt

Contacts

CONTACTwafaa hamada abdu, master
wh8119712@gmail.com+20 1061583899
PRINCIPAL_INVESTIGATORwafaa hamada abdu, master

alazhar univristy for boys

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026