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NCT Number: NCT07795242

AI in MF Diagnosis

The aim of this observational study is to evaluate the diagnostic performance of an AI algorithm in the histopathological diagnosis of MF compared to certified dermatopathologists.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine , Al Azhar university , Nasr city , Cairo , Egypt

Cairo, Egypt

About this study

Mycosis fungoides (MF) is the most common form of primary cutaneous T-cell lymphoma. Its early histological features may overlap with benign inflammatory dermatoses, making diagnosis challenging.

This observational study aims to evaluate the diagnostic performance of HistoGPT in the histopathological diagnosis of MF compared with certified dermatopathologists.

H&E-stained skin biopsy slides will be digitized using a Leica Aperio GT450 whole-slide scanner at 40× magnification.

The resulting whole-slide images will be analyzed using HistoGPT, an AI-based histopathology platform.

The diagnostic performance of HistoGPT and certified dermatopathologists will be assessed and compared using appropriate diagnostic metrics, including accuracy, sensitivity, specificity, F1 score, and area under the ROC curve.

The findings of this study will help determine whether Artificial intelligence can serve as a diagnostic support tool for the histopathological diagnosis of mycosis fungoides.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Slides will be included in the study if they meet the following criteria:
  • Histopathological slides diagnosed as MF.
  • Slides with adequate staining and preservation allowing clear visualization of histopathological features.

Exclusion criteria

  • Slides will be excluded if they meet any of the following criteria:
  • Slides with poor staining quality or significant artifacts interfering with histopathological interpretation.
  • Slides that were damaged, faded, or inadequately preserved.
  • Slides 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

this study does not include any intervention

Other

Does not include intervention

Primary outcomes

  1. The accuracy of artificial intelligence in histopathological diagnosis of Mycosis fungoides will be evaluated by sensitivity and specificity

    Time frame: 1 year

Study contacts

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

Shimaa Ali Ahmed, Resident of dermatology

CONTACT

[email protected]

+201024466776

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 Mycosis Fungoides

Acronym: AI\MF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 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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