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- Ensayo clínico 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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Kasr Al-Aini Hospitals, Cairo University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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MF
Patients diagnosed histopathologically as mycosis fungoides
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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. |
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PLC/PLEVA
Patients diagnosed histopathologically as PLC or PLEVA
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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. |
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TCD
Patients diagnosed histopathologically as T cell dyscrasia
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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. |
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BCL
Patients diagnosed histopathologically as B cell lymphoma
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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. |
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Pseudolymphoma
Patients diagnosed histopathologically as pseudo lymphoma
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diagnostic accuracy of AI model
Periodo de tiempo: Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
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Accuracy, sensitivity, specificity, and positive predictive value of the trained AI models in differentiating benign CLPDs from malignant types.
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Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparison with dermatopathologists
Periodo de tiempo: Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
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Compare AI model diagnostic accuracy with that of experienced dermatopathologists
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Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
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Smartphone imaging feasibility
Periodo de tiempo: Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
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Assess feasibility and diagnostic accuracy of AI models using smartphone-captured histopathology images.
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Baseline (In retrospective diagnostic studies, the moment the AI evaluates the historical slide is considered the patients's baseline).
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Zama D, Borghesi A, Ranieri A, Manieri E, Pierantoni L, Andreozzi L, Dondi A, Neri I, Lanari M, Calegari R. Perspectives and Challenges of Telemedicine and Artificial Intelligence in Pediatric Dermatology. Children (Basel). 2024 Nov 19;11(11):1401. doi: 10.3390/children11111401.
- Valencia Ocampo OJ, Julio L, Zapata V, Correa LA, Vasco C, Correa S, Velasquez-Lopera MM. Mycosis Fungoides in Children and Adolescents: A Series of 23 Cases. Actas Dermosifiliogr (Engl Ed). 2020 Mar;111(2):149-156. doi: 10.1016/j.ad.2019.04.004. Epub 2019 Jul 2. English, Spanish.
- Rashad, N. M., Abdelnapi, N. Mm., Seddik, A. F., & Sayedelahl, M. A. (2025). Automating skin cancer screening: A deep learning. Journal of Engineering and Applied Science, 72(1), 6. https://doi.org/10.1186/s44147-024-00573-w
- Floridi, L. (2019). Establishing the rules for building trustworthy AI. Nature Machine Intelligence, 1(6), 261-262. https://doi.org/10.1038/s42256-019-0055-y
- Foss FM, Girardi M. Mycosis Fungoides and Sezary Syndrome. Hematol Oncol Clin North Am. 2017 Apr;31(2):297-315. doi: 10.1016/j.hoc.2016.11.008.
- Gomolin A, Netchiporouk E, Gniadecki R, Litvinov IV. Artificial Intelligence Applications in Dermatology: Where Do We Stand? Front Med (Lausanne). 2020 Mar 31;7:100. doi: 10.3389/fmed.2020.00100. eCollection 2020.
- Hodak E, Geskin L, Guenova E, Ortiz-Romero PL, Willemze R, Zheng J, Cowan R, Foss F, Mangas C, Querfeld C. Real-Life Barriers to Diagnosis of Early Mycosis Fungoides: An International Expert Panel Discussion. Am J Clin Dermatol. 2023 Jan;24(1):5-14. doi: 10.1007/s40257-022-00732-w. Epub 2022 Nov 18.
- Jartarkar SR. Artificial intelligence: Its role in dermatopathology. Indian J Dermatol Venereol Leprol. 2023 Jul-Aug;89(4):549-552. doi: 10.25259/IJDVL_725_2021.
- Kempf W, Mitteldorf C, Cerroni L, Willemze R, Berti E, Guenova E, Scarisbrick JJ, Battistella M. Classifications of cutaneous lymphomas and lymphoproliferative disorders: An update from the EORTC cutaneous lymphoma histopathology group. J Eur Acad Dermatol Venereol. 2024 Aug;38(8):1491-1503. doi: 10.1111/jdv.19987. Epub 2024 Apr 6.
- Kent MN, Olsen TG, Feeser TA, Tesno KC, Moad JC, Conroy MP, Kendrick MJ, Stephenson SR, Murchland MR, Khan AU, Peacock EA, Brumfiel A, Bottomley MA. Diagnostic Accuracy of Virtual Pathology vs Traditional Microscopy in a Large Dermatopathology Study. JAMA Dermatol. 2017 Dec 1;153(12):1285-1291. doi: 10.1001/jamadermatol.2017.3284.
- Ottevanger R, de Bruin DT, Willemze R, Jansen PM, Bekkenk MW, de Haas ERM, Horvath B, van Rossum MM, Sanders CJG, Veraart JCJM, Vermeer MH, Quint KD. Incidence of mycosis fungoides and Sezary syndrome in the Netherlands between 2000 and 2020. Br J Dermatol. 2021 Aug;185(2):434-435. doi: 10.1111/bjd.20048. Epub 2021 May 4. No abstract available.
- Polesie S, McKee PH, Gardner JM, Gillstedt M, Siarov J, Neittaanmaki N, Paoli J. Attitudes Toward Artificial Intelligence Within Dermatopathology: An International Online Survey. Front Med (Lausanne). 2020 Oct 20;7:591952. doi: 10.3389/fmed.2020.591952. eCollection 2020.
- Tsianakas A, Kienast AK, Hoeger PH. Infantile-onset cutaneous T-cell lymphoma. Br J Dermatol. 2008 Dec;159(6):1338-41. doi: 10.1111/j.1365-2133.2008.08794.x. Epub 2008 Aug 19.
- Willemze R. Cutaneous lymphoproliferative disorders: Back to the future. J Cutan Pathol. 2024 Jun;51(6):468-476. doi: 10.1111/cup.14609. Epub 2024 Mar 18.
- Fatima S, Siddiqui S, Tariq MU, Ishtiaque H, Idrees R, Ahmed Z, Ahmed A. Mycosis Fungoides: A Clinicopathological Study of 60 Cases from a Tertiary Care Center. Indian J Dermatol. 2020 Mar-Apr;65(2):123-129. doi: 10.4103/ijd.IJD_602_18.
- Esteva A, Robicquet A, Ramsundar B, Kuleshov V, DePristo M, Chou K, Cui C, Corrado G, Thrun S, Dean J. A guide to deep learning in healthcare. Nat Med. 2019 Jan;25(1):24-29. doi: 10.1038/s41591-018-0316-z. Epub 2019 Jan 7.
- Doeleman T, Hondelink LM, Vermeer MH, van Dijk MR, Schrader AMR. Artificial intelligence in digital pathology of cutaneous lymphomas: A review of the current state and future perspectives. Semin Cancer Biol. 2023 Sep;94:81-88. doi: 10.1016/j.semcancer.2023.06.004. Epub 2023 Jun 17.
- Chan S, Reddy V, Myers B, Thibodeaux Q, Brownstone N, Liao W. Machine Learning in Dermatology: Current Applications, Opportunities, and Limitations. Dermatol Ther (Heidelb). 2020 Jun;10(3):365-386. doi: 10.1007/s13555-020-00372-0. Epub 2020 Apr 6.
- Cazzato G, Rongioletti F. Artificial intelligence in dermatopathology: Updates, strengths, and challenges. Clin Dermatol. 2024 Sep-Oct;42(5):437-442. doi: 10.1016/j.clindermatol.2024.06.010. Epub 2024 Jun 21.
- Amorim GM, Quintella DC, Niemeyer-Corbellini JP, Ferreira LC, Ramos-E-Silva M, Cuzzi T. Validation of an algorithm based on clinical, histopathological and immunohistochemical data for the diagnosis of early-stage mycosis fungoides. An Bras Dermatol. 2020 May-Jun;95(3):326-331. doi: 10.1016/j.abd.2020.01.002. Epub 2020 Mar 20.
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Términos relacionados con este estudio
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Otros números de identificación del estudio
- MD-152-2025
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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Ensayos clínicos sobre AI-assisted histopathology image analysis
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Francesco De CobelliReclutamientoHepatectomía | Ablación del hígado | Resección del hígado | Metástasis al hígado colorrectal (CRLM)Italia