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NCT07705386Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 15 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
463 (estimated)
First submitted
30 Jun 2026
Start date
1 Jan 2026
Primary completion date
30 Nov 2026
Lead sponsor
Cairo University
NCT number
NCT07705386

What you commit to

  • Study type: Observational
  • Planned participants: 463
  • From 1 Jan 2026 to the primary completion date, 30 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Slides with significant artifacts (folding, tearing, poor staining) that prevent adequate image analysis.
  • Cases with insufficient clinical or pathological data for definitive diagnosis.
  • Cases with secondary cutaneous CLPDs

Who the study is looking for

  • Archived slides of patients with a confirmed histopathological diagnosis of malignant CLPDs (e.g., mycosis fungoides at all stages, cutaneous B-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, lymphomatoid papulosis), based on WHO-EORTC criteria.
  • Archived slides of patients with benign CLPDs that mimic MF clinically and histologically (e.g., pseudolymphoma, pityriasis lichenoides chronica, pityriasis lichenoides et varioliformis acuta \[PLEVA\]).
  • Availability of adequate quality hematoxylin and eosin (H\&E) stained slides.
  • Availability of relevant clinical data (age, sex, disease duration, distribution of lesions, drug history).

Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kasr Al-Aini Hospitals, Cairo University
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.