跳至主要内容
临床试验/NCT05284929
NCT05284929Unknown不适用

Increased Frequencies of Certain HLA Class II Alleles DRB1 and DQB1 in PV Patients Compared to Those in Healthy Donors Have Been Reported in Various Populations and Repeatedly Confirmed. Among the Russian Population, no Studies About the Association of PV and HLA Class II Genes Have Been Conducted. Thus, the Purpose of This Study Was to Investigate HLA Class II Alleles and Haplotypes in Russian Patients With Pemphigus Vulgaris.

Sechenov University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年5月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Estimation of HLA-DRB1 and HLA-DQB1 alleles frequencies in PV patients and controls

研究概览

简要总结

Pemphigus is a rare autoimmune life-threatening blistering condition affecting skin and mucous membranes. Pemphigus belongs to a family of polygenic disorders. Several different genes encoding molecules regulate pemphigus autoimmunity. Many trials focused on HLA investigation. Increased levels of certain HLA class II alleles frequencies in pemphigus have been reported in various populations. However, they were not investigated in the Russian population.

The aim of our study is to investigate HLA class II alleles and haplotypes in Russian patients with pemphigus.

Methods

Patients and controls

We are recruiting 120 patients with pemphigus. The diagnosis was based on clinical and histopathological findings and confirmed by immunofluorescent techniques (direct and indirect immunofluorescent tests). Before sampling, written consent was obtained from each subject. A single blood sample for HLA typing was obtained from all subjects. This study has been approved by the Ethics Committee of Sechenov University, Russia. Phenotypic and allelic frequencies were compared with healthy blood donors (n=100) registered in Sechenov University blood center.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Age of patients >18 years
  • Confirmed diagnosis

排除标准

  • No as pemphigus is a life-threatening condition

结局指标

主要结局

Estimation of HLA-DRB1 and HLA-DQB1 alleles frequencies in PV patients and controls

时间窗: May 2017 - 2023

The frequencies of HLA alleles will be counted directly from genotyping data, while the frequencies of haplotypes will be estimated with an expectation-maximization algorithm using the ARLEQUIN software package (version 3.11), leading to maximum-likelihood estimates of gene frequencies. To compare the differences between frequencies in the donor and patient groups the Fisher exact test will be performed.

次要结局

未报告次要终点

研究者

发起方
Sechenov University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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