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Development of an AI-Assisted Diagnostic Tool for Mycosis Fungoides and Other Cutaneous Lymphoproliferative Diseases Using Microscopic Image Analysis: A Training and Validation Study

NCT07705386 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 463

Last updated 2026-07-15

No results posted yet for this study

Summary

Cutaneous lymphoproliferative diseases (CLPDs) are a group of skin disorders that range from benign conditions, such as pseudolymphomas, to malignant forms like cutaneous T-cell and B-cell lymphomas. Mycosis fungoides is the most common malignant type, but diagnosis is often difficult because many benign skin conditions can mimic lymphoma. Current diagnostic methods rely on microscopic examination of biopsies, which can be subjective and vary between pathologists.

This study aims to develop and validate a deep learning model that uses digitized biopsy images and clinical data to distinguish malignant CLPDs from benign ones. By applying artificial intelligence to dermatopathology, the project seeks to improve diagnostic accuracy, reduce variability, and support clinicians in making timely treatment decisions. The novelty of this work lies in applying advanced AI methods to a rare and challenging group of skin diseases, with the potential to enhance patient care in both specialized centers and resource-limited settings.

Conditions

  • Cutaneous Lymphoproliferative Diseases
  • Mycosis Fungoides of Skin (Diagnosis)
  • T Cell Dyscrasia
  • PLEVA-PLC Spectrum
  • Pseudolymphoma
  • Primary Cutaneous B-Cell Lymphoma (CBCL)

Interventions

DIAGNOSTIC_TEST

AI-assisted histopathology image analysis

Development and validation of a deep learning model using digitized hematoxylin and eosin (H\&E) stained slides and clinical data to differentiate malignant CLPDs from benign mimickers. Comparator: Standard histopathological diagnosis by experienced dermatopathologists.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705386 on ClinicalTrials.gov