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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

14 luglio 2026 aggiornato da: Kariman Mostafa Sayed Mansour, Cairo University

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.

Panoramica dello studio

Descrizione dettagliata

Cutaneous lymphoproliferative diseases (CLPDs) encompass both benign and malignant disorders, ranging from pseudolymphomas to cutaneous T-cell and B-cell lymphomas. Mycosis fungoides (MF) is the most common malignant subtype, but diagnosis is often challenging because benign inflammatory conditions can closely mimic lymphoma. Histopathological examination remains the gold standard, yet interpretation is subjective and prone to inter-observer variability. This highlights the need for standardized diagnostic tools, including artificial intelligence (AI) solutions.

This study is a retrospective diagnostic accuracy investigation using routinely collected data. Archived hematoxylin and eosin (H&E) stained slides of patients with MF and other CLPDs will be retrieved from the Dermatopathology Unit at Kasr Al-Aini Hospitals, Cairo University. Slides of benign mimickers such as pseudolymphoma and pityriasis lichenoides will also be included. Cases with poor slide quality or insufficient data will be excluded.

Digitized images will be captured using both high-resolution microscope cameras and standardized smartphone devices to evaluate feasibility. Experienced dermatopathologists will annotate regions of interest, and relevant clinical data will be extracted to build a structured database. Deep learning models, particularly convolutional neural networks (CNNs), will be trained and validated on these datasets. Preprocessing techniques such as color normalization, stain separation, and data augmentation will be applied to enhance robustness.

The primary outcomes are diagnostic accuracy, sensitivity, specificity, and predictive values of the AI models in differentiating malignant from benign CLPDs, and in staging MF. Secondary outcomes include comparison with expert dermatopathologists, assessment of smartphone-based imaging, and evaluation across magnification levels. More than 500 slides collected over the past five years will be used, divided into training, validation, and testing sets.

By integrating AI into dermatopathology, this study aims to reduce diagnostic variability, improve accuracy, and explore novel imaging approaches. The work represents one of the first applications of deep learning to CLPDs, with potential to enhance patient care in both specialized centers and resource-limited healthcare settings.

Tipo di studio

Osservativo

Iscrizione (Stimato)

463

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Cairo, Egitto
        • Kasr Al-Aini Hospitals, Cairo University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Archived slides of patients diagnosed with malignant CLPDs (e.g., mycosis fungoides, cutaneous B-cell lymphoma) and benign mimickers (e.g., pseudolymphoma, pityriasis lichenoides chronica, PLEVA) were identified from the pathology database of Kasr Al-Aini Hospitals, Cairo University.

Cases were selected based on WHO-EORTC diagnostic criteria and availability of adequate quality H&E slides plus relevant clinical data.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
MF
Patients diagnosed histopathologically as mycosis fungoides

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.

PLC/PLEVA
Patients diagnosed histopathologically as PLC or PLEVA

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.

TCD
Patients diagnosed histopathologically as T cell dyscrasia

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.

BCL
Patients diagnosed histopathologically as B cell lymphoma

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.

Pseudolymphoma
Patients diagnosed histopathologically as pseudo lymphoma

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic accuracy of AI model
Lasso di tempo: Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
Accuracy, sensitivity, specificity, and positive predictive value of the trained AI models in differentiating benign CLPDs from malignant types.
Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comparison with dermatopathologists
Lasso di tempo: Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
Compare AI model diagnostic accuracy with that of experienced dermatopathologists
Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
Smartphone imaging feasibility
Lasso di tempo: Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
Assess feasibility and diagnostic accuracy of AI models using smartphone-captured histopathology images.
Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

15 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • MD-152-2025

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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