NCT07795242

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Dec 2027

First Submitted

Initial submission to the registry

August 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 25, 2026

Last Update Submit

August 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    1 year

Interventions

Does not include intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pathology specimens stained with H\&E stains from MF lesions

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shimaa Ali Ahmed

    Al Azhar university for boys

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shimaa Ali Ahmed, Resident of dermatology

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Dermatologist

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 31, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 31, 2026

Record last verified: 2026-08

Locations