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Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population

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ClinicalTrials.gov Identifier: NCT05284929
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Collaborator:
Pirogov Russian National Research Medical University
Information provided by (Responsible Party):
Sechenov University

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.


Condition or disease Intervention/treatment
Pemphigus Bullous Pemphigoid Stevens-Johnson Syndrome Toxic Epidermal Necrolyses Genetic: A single blood sample for HLA typing

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: 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.
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : November 17, 2022
Estimated Study Completion Date : March 17, 2023


Group/Cohort Intervention/treatment
Patients with pemphigus Genetic: A single blood sample for HLA typing
Extracting of DNA from the blood sample using PCR-reaction

Healthy controls Genetic: A single blood sample for HLA typing
Extracting of DNA from the blood sample using PCR-reaction




Primary Outcome Measures :
  1. Estimation of HLA-DRB1 and HLA-DQB1 alleles frequencies in PV patients and controls [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

120 patients with confirmed diagnosis of pemphigus will be enrolled in the study Age >18 years Sex: both females and males

100 healthy controls

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No as pemphigus is a life-threatening condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05284929


Locations
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Russian Federation
Sechenov University Recruiting
Moscow, Russian Federation, 119991
Contact: Anfisa Lepekhova, PhD    +79035433074    anfisa.lepehova@yandex.ru   
Sponsors and Collaborators
Sechenov University
Pirogov Russian National Research Medical University
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Responsible Party: Sechenov University
ClinicalTrials.gov Identifier: NCT05284929    
Other Study ID Numbers: #03-22
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pemphigus
Stevens-Johnson Syndrome
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Erythema Multiforme
Erythema
Hypersensitivity, Delayed
Hypersensitivity
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders