Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC) (BP-EPIC)
14 de junio de 2026 actualizado por: MURAT OZKAN, Istanbul Training and Research Hospital
Correlation of Disease Severity With Histopathological Features, Serum IgE Levels, Eosinophil Count, and Tissue Expression of Eosinophilic Cationic Protein and Periostin in Patients With Bullous Pemphigoid
Bullous pemphigoid is an autoimmune subepidermal blistering disease characterized by eosinophilic inflammation and variable disease severity. This retrospective observational study aims to evaluate the relationship between disease severity and histopathological features, serum IgE levels, peripheral eosinophil counts, and the expression of eosinophilic cationic protein (ECP) and periostin in skin biopsy specimens of patients with bullous pemphigoid.
Immunohistochemical staining for ECP and periostin will be assessed semi-quantitatively and correlated with clinical and laboratory parameters, including BPDAI scores, eosinophil counts, serum IgE levels, hospitalization history, and disease relapse. The study seeks to identify potential tissue biomarkers associated with disease activity and severity in bullous pemphigoid.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
Bullous pemphigoid (BP) is the most common autoimmune subepidermal blistering disease and is characterized by autoantibodies directed against hemidesmosomal proteins. Eosinophils and eosinophil-associated mediators are believed to play a central role in disease pathogenesis. Periostin and eosinophilic cationic protein (ECP) have been implicated in eosinophilic inflammation; however, their relationship with clinical disease severity in BP remains incompletely understood.
This single-center retrospective observational study will include patients diagnosed with bullous pemphigoid at the University of Health Sciences, Istanbul Training and Research Hospital. Clinical, laboratory, and histopathological data will be collected from medical records.
The study will evaluate demographic characteristics, disease severity measured by BPDAI, serum IgE levels, peripheral eosinophil counts, hospitalization history, relapse frequency, and other clinicopathological parameters. Archived skin biopsy specimens will undergo immunohistochemical staining for periostin and ECP. Staining intensity will be assessed using semi-quantitative scoring methods and correlated with clinical and laboratory findings.
The primary objective is to determine whether periostin and ECP expression levels are associated with disease severity. Secondary objectives include evaluating correlations between tissue biomarker expression and serum IgE levels, eosinophil counts, hospitalization, and disease recurrence.
Tipo de estudio
De observación
Inscripción (Estimado)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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FATİH
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Istanbul, FATİH, Turquía (Türkiye), 34096
- S.B.Ü. İstanbul Eğitim ve Araştırma Hastanesi
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult patients diagnosed with bullous pemphigoid and followed at the University of Health Sciences, Istanbul Training and Research Hospital.
Participants will be identified retrospectively from hospital records and pathology archives.
Clinical, laboratory, and histopathological data, including BPDAI scores, serum IgE levels, peripheral eosinophil counts, and immunohistochemical expression of periostin and eosinophilic cationic protein, will be evaluated.
Descripción
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of bullous pemphigoid confirmed by compatible clinical, histopathological, and/or direct immunofluorescence findings.
- Availability of archived skin biopsy specimens suitable for immunohistochemical evaluation of periostin and eosinophilic cationic protein (ECP).
- Availability of clinical and laboratory data, including BPDAI score, serum IgE level, and peripheral eosinophil count.
Exclusion Criteria:
- Age <18 years.
- Diagnosis other than bullous pemphigoid.
- Inadequate or unavailable biopsy specimens for immunohistochemical analysis.
- Missing clinical, histopathological, or laboratory data required for study analyses.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Bullous Pemphigoid Patients
Patients with bullous pemphigoid included in a retrospective observational study evaluating the relationship between disease severity and periostin and ECP expression in skin biopsy specimens.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between BPDAI Score and Periostin Immunohistochemical Expression
Periodo de tiempo: Baseline (retrospective assessment of existing clinical and histopathological data)
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Correlation between BPDAI disease activity score and periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens from patients with bullous pemphigoid.
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Baseline (retrospective assessment of existing clinical and histopathological data)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between Periostin Immunohistochemical Expression and Serum Total IgE Levels
Periodo de tiempo: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data
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Correlation between periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and serum total IgE levels (IU/mL) in patients with bullous pemphigoid.
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Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data
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Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Peripheral Blood Eosinophil Count
Periodo de tiempo: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
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Correlation between eosinophilic cationic protein (ECP) immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and peripheral blood eosinophil count (cells/µL) in patients with bullous pemphigoid.
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Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
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Correlation Between Periostin Expression and Disease Relapse Frequency
Periodo de tiempo: Baseline (retrospective assessment of existing clinical and histopathological data
|
Correlation between periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and disease relapse frequency (number of relapses) in patients with bullous pemphigoid.
|
Baseline (retrospective assessment of existing clinical and histopathological data
|
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Correlation Between Periostin Immunohistochemical Expression and Hospitalization History
Periodo de tiempo: Baseline (retrospective assessment of existing clinical and histopathological data)
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Correlation between periostin immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and hospitalization history (yes/no) in patients with bullous pemphigoid.
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Baseline (retrospective assessment of existing clinical and histopathological data)
|
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Correlation Between Eosinophilic Cationic Protein Expression and Disease Relapse Frequency
Periodo de tiempo: Baseline (retrospective assessment of existing clinical and histopathological data)
|
Correlation between eosinophilic cationic protein (ECP) immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and disease relapse frequency (number of relapses) in patients with bullous pemphigoid.
|
Baseline (retrospective assessment of existing clinical and histopathological data)
|
|
Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Hospitalization History
Periodo de tiempo: Baseline (retrospective assessment of existing clinical and histopathological data)
|
Correlation between eosinophilic cationic protein (ECP) immunohistochemical expression measured using a semiquantitative 0-3 staining score in skin biopsy specimens and hospitalization history (yes/no) in patients with bullous pemphigoid.
|
Baseline (retrospective assessment of existing clinical and histopathological data)
|
|
Correlation Between BPDAI Score and Eosinophilic Cationic Protein Expression
Periodo de tiempo: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
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Correlation between BPDAI disease activity score and tissue eosinophilic cationic protein (ECP) expression assessed by immunohistochemistry using a semiquantitative 0-3 staining score in skin biopsy specimens from patients with bullous pemphigoid.
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Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Ayse Esra Koku Aksu, Prof.Dr., University of Health Sciences, Istanbul Training and Research Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de mayo de 2026
Finalización primaria (Estimado)
24 de diciembre de 2026
Finalización del estudio (Estimado)
25 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SBU-IEAH-KAEK-20262404-26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data (IPD) will not be shared.
This retrospective, single-center study uses patient data collected as part of routine clinical care.
Data sharing is restricted due to institutional policies, ethical considerations, and patient confidentiality requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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