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Not yet recruitingNCT07795242AI\MFUpdated Aug 31, 2026

AI in MF Diagnosis

An observational study in Mycosis Fungoides of Skin (Diagnosis) and Artificial Intelligence (AI) in Diagnosis, sponsored by Al-Azhar University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-08-31.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
50
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Al-Azhar University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

H\&E stained glass slides of MF cases will be collected from the pathology archive of Al hussein dermatopathology unit

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherthis study does not include any intervention

    Does not include intervention

06

What researchers measure

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

07

Study locations

1 site
  • Faculty of Medicine , Al Azhar university , Nasr city , Cairo , Egypt
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Aug 31, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Oct 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07795242
Lead sponsor
Al-Azhar University
Responsible party
Shimaa Ali Ahmed (Resident Dermatologist, Al-Azhar University) — Principal investigator
First posted
Aug 31, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Shimaa Ali Ahmed, Resident of dermatology
Contact
shimaaali038@gmail.com
+201024466776
Shimaa Ali Ahmed
principal investigator · Al Azhar university for boys

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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