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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05284929
Other study ID # #03-22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 17, 2017
Est. completion date March 17, 2023

Study information

Verified date March 2022
Source Sechenov University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 17, 2023
Est. primary completion date November 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Signed informed consent - Age of patients >18 years - Confirmed diagnosis Exclusion Criteria: - No as pemphigus is a life-threatening condition

Study Design


Intervention

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

Locations

Country Name City State
Russian Federation Sechenov University Moscow

Sponsors (2)

Lead Sponsor Collaborator
Sechenov University Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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