← Back to all trials
Active Not Recruiting
NCT07705386
Development of an AI-Assisted Diagnostic Tool for Mycosis Fungoides and Other Cutaneous Lymphoproliferative Diseases Using Microscopic Image Analysis: A Training and Validation Study
Conditions: Cutaneous Lymphoproliferative Diseases, Mycosis Fungoides of Skin (Diagnosis), T Cell Dyscrasia, PLEVA-PLC Spectrum, Pseudolymphoma, Primary Cutaneous B-Cell Lymphoma (CBCL)
Sex: All
Enrollment: 463
Sponsor: Cairo University
Location: Kasr Al-Aini Hospitals, Cairo University Cairo
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.
Eligibility Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07705386). StuddyBuddy aggregates publicly available trial information.