NCT07787481

Brief Summary

The aim of this study is to evaluate the diagnostic performance of an Artificial Intelligence (AI) algorithm in the histopathological diagnosis of Seborrheic keratosis compared to Certified Dermatopathologists.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 23, 2026

Last Update Submit

August 23, 2026

Conditions

Seborrheic KeratosesArtifical Intelligence

Outcome Measures

Primary Outcomes (1)

  • The accuracy of the artificial intelligence algorithm in histopathological diagnosis of seborrheic keratosis evaluated mainly by sensitivity and specificity.

    1 year

Interventions

This study doesn't include an intervention.OTHER

This study doesn't include an intervention.

Eligibility Criteria

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

Seborrheic keratosis H\&E stained glass slides from the pathology archive of Al-hussein dermatopathology unit.

You may qualify if:

  • Histopathological slides diagnosed as Seborrheic keratosis.
  • Slides with adequate staining and preservation allowing clear visualization of histopathological features.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Al-Azhar University boys branch in Cairo

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pathology specimens of seborrheic keratosis lesions

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Hebatullah Fouad Elkerm

CONTACT

+201111075736hebaf.alkerm@gmail.com

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 23, 2026

First Posted

August 26, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations

EG(1)