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临床试验/CTRI/2025/04/084468
CTRI/2025/04/084468尚未招募不适用

To Compare the Utility of Immunofluorescence Techniques [Direct and Indirect Immunofluorescence with Salt-Split Skin Assay], Biochip Mosaic Assay, and Multiplex ELISA in the Diagnosis of Autoimmune Bullous Diseases – A Prospective Cross-Sectional Pilot Study

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
85
试验地点
1
主要终点
To assess the utility of

研究概览

简要总结

To the best of our knowledge there is paucity of studies in literature comparing the utility of various immunofluorescence assays (DIF, IIF with salt-split skin assay), biochip mosaic assay and serodiagnosis by Multiplex ELISA test in the diagnosis of AIBDs. We will be comparing the sensitivity, specificity, positive predictive value and negative predictive value of all these assays in the diagnosis of AIBDs

Study design: Prospective cross-sectional pilot study. Duration of study: 2 years Jan 2025 from to Jan 2027) Number of patients: At least 50 cases and 35 controls will be recruited.

We will be recruiting total of 35 controls in the project Disease controls – 25 Healthy controls – 10 All patients attending the out-patient department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, will be screened for active cases of AIBDs (both intraepidermal and sub epidermal), for recruitment into the study. Control patients (both diseased and healthy controls) will also be recruited. Cases- Skin biopsy samples and sera of at least 50 confirmed (combination of clinical, histopathological features and IB assay) cases of active AIBDs (both intraepidermal and subepidermal diseases), will be subjected to immunofluorescence assays (DIF, IIF with salt-split skin assay), Biochip mosaic assay and Multiplex ELISA. The diagnosis of AIBD will be confirmed on the basis of clinical features, histopathological examination, and immunoblot assay. Definitive diagnosis - Immunoblot assay, clinical assessment and histopathological examination- all three are positive. Probable diagnosis – Clinical and histopathological examination are positive Cases will be taken on the basis of probable diagnosis initially for the recruitment

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Active cases of autoimmune bullous diseases (AIBDs), both intraepidermal and subepidermal, of any age and gender, diagnosed on the basis of clinical features, histopathological examination and Immunoblot assay (for detection of specific antigens).
  • 2.Patients giving consent for participation in the study and obtaining skin biopsy (lesional and perilesional normal skin) and venous blood samples.

排除标准

  • 1.Patients of AIBDs with inactive disease.
  • 2.Patients who are on oral immunosuppressive therapy other than oral corticosteroids (≤20mg/day) for past 4 weeks or have received rituximab in past 6 months.
  • 3.Patients who are transplant recipients or on chemotherapy, or any major immunosuppression.
  • 4.Pregnant and lactating women.

结局指标

主要结局

To assess the utility of

时间窗: Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

immunofluorescence (IF) techniques (direct

时间窗: Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

immunofluorescence, indirect immunofluorescence

时间窗: Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

with salt-split skin assay) in the diagnosis of

时间窗: Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

autoimmune bullous diseases (AIBDs)

时间窗: Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

次要结局

  • Comparison of IF techniques(with Biochip mosaic assay & Multiplex ELISA)

研究者

发起方
AIIMS NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sujay Khandpur

AIIMS NEW DELHI

研究点 (1)

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