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

NCT ID: NCT05284929

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-17

Study Completion Date

2023-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Pemphigus Bullous Pemphigoid Stevens-Johnson Syndrome Toxic Epidermal Necrolyses

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with pemphigus

A single blood sample for HLA typing

Intervention Type GENETIC

Extracting of DNA from the blood sample using PCR-reaction

Healthy controls

A single blood sample for HLA typing

Intervention Type GENETIC

Extracting of DNA from the blood sample using PCR-reaction

Interventions

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A single blood sample for HLA typing

Extracting of DNA from the blood sample using PCR-reaction

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age of patients \>18 years
* Confirmed diagnosis

Exclusion Criteria

* No as pemphigus is a life-threatening condition
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pirogov Russian National Research Medical University

OTHER

Sponsor Role collaborator

Sechenov University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sechenov University

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Anfisa Lepekhova, PhD

Role: primary

+79035433074

Other Identifiers

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#03-22

Identifier Type: -

Identifier Source: org_study_id

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