Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC) (BP-EPIC)
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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FATİH
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Istanbul, FATİH, 터키 (Türkiye), 34096
- S.B.Ü. İstanbul Eğitim ve Araştırma Hastanesi
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation Between BPDAI Score and Periostin Immunohistochemical Expression
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation Between Periostin Immunohistochemical Expression and Serum Total IgE Levels
기간: 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
기간: 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
기간: 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 disease relapse frequency (number of relapses) in patients with bullous pemphigoid.
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Baseline (retrospective assessment of existing clinical and histopathological data
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Correlation Between Periostin Immunohistochemical Expression and Hospitalization History
기간: 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
기간: Baseline (retrospective assessment of existing clinical 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 disease relapse frequency (number of relapses) 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 Immunohistochemical Expression and Hospitalization History
기간: Baseline (retrospective assessment of existing clinical 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 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 BPDAI Score and Eosinophilic Cationic Protein Expression
기간: 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)
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공동 작업자 및 조사자
수사관
- 연구 의자: Ayse Esra Koku Aksu, Prof.Dr., University of Health Sciences, Istanbul Training and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SBU-IEAH-KAEK-20262404-26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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