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Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC) (BP-EPIC)

14. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

50

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • FATİH
      • Istanbul, FATİH, Türkei (türkiye), 34096
        • S.B.Ü. İstanbul Eğitim ve Araştırma Hastanesi

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation Between BPDAI Score and Periostin Immunohistochemical Expression
Zeitfenster: Baseline (retrospective assessment of existing clinical and histopathological data)
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.
Baseline (retrospective assessment of existing clinical and histopathological data)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation Between Periostin Immunohistochemical Expression and Serum Total IgE Levels
Zeitfenster: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data
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.
Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data
Correlation Between Eosinophilic Cationic Protein Immunohistochemical Expression and Peripheral Blood Eosinophil Count
Zeitfenster: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
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.
Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
Correlation Between Periostin Expression and Disease Relapse Frequency
Zeitfenster: 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
Correlation Between Periostin Immunohistochemical Expression and Hospitalization History
Zeitfenster: 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 hospitalization history (yes/no) in patients with bullous pemphigoid.
Baseline (retrospective assessment of existing clinical and histopathological data)
Correlation Between Eosinophilic Cationic Protein Expression and Disease Relapse Frequency
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)
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.
Baseline (retrospective assessment of existing clinical, laboratory, and histopathological data)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Istanbul Training and Research Hospital

Ermittler

  • Studienstuhl: Ayse Esra Koku Aksu, Prof.Dr., University of Health Sciences, Istanbul Training and Research Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Mai 2026

Primärer Abschluss (Geschätzt)

24. Dezember 2026

Studienabschluss (Geschätzt)

25. April 2027

Studienanmeldedaten

Zuerst eingereicht

8. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SBU-IEAH-KAEK-20262404-26

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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