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AI in MF Diagnosis

Evaluation of Artificial Intelligence Algorithms Performance in the Histopathological Diagnosis of Mycosis Fungoides

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07795242
Acronym
AI\MF
Enrollment
50
Registered
2026-08-31
Start date
2026-10-01
Completion date
2027-12-01
Last updated
2026-08-31

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

Conditions

Artificial Intelligence (AI) in Diagnosis, Mycosis Fungoides of Skin (Diagnosis)

Brief summary

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.

Detailed description

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.

Interventions

OTHERthis study does not include any intervention

Does not include intervention

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The accuracy of artificial intelligence in histopathological diagnosis of Mycosis fungoides will be evaluated by sensitivity and specificity1 year

Countries

Egypt

Contacts

CONTACTShimaa Ali Ahmed, Resident of dermatology
shimaaali038@gmail.com+201024466776
PRINCIPAL_INVESTIGATORShimaa Ali Ahmed

Al Azhar university for boys

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026