Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
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.
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2017
CompletedFirst Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2023
CompletedMarch 17, 2022
March 1, 2022
5.5 years
March 10, 2022
March 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Estimation of HLA-DRB1 and HLA-DQB1 alleles frequencies in PV patients and controls
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.
May 2017 - 2023
Study Arms (2)
Patients with pemphigus
Healthy controls
Interventions
Extracting of DNA from the blood sample using PCR-reaction
Eligibility Criteria
120 patients with confirmed diagnosis of pemphigus will be enrolled in the study Age \>18 years Sex: both females and males 100 healthy controls
You may qualify if:
- Signed informed consent
- Age of patients \>18 years
- Confirmed diagnosis
You may not qualify if:
- No as pemphigus is a life-threatening condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sechenov University
Moscow, 119991, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 17, 2022
Study Start
May 17, 2017
Primary Completion
November 17, 2022
Study Completion
March 17, 2023
Last Updated
March 17, 2022
Record last verified: 2022-03