An observational study in Pemphigus, Bullous Pemphigoid and Stevens-Johnson Syndrome, sponsored by Sechenov University. Status unknown at 1 site in Russian Federation. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Sechenov University · Observational
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 21 observational studies indexed under Pemphigus.
Browse Pemphigus studies →Sechenov University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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120 patients with confirmed diagnosis of pemphigus will be enrolled in the study Age >18 years Sex: both females and males
100 healthy controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genetic: A single blood sample for HLA typing
Genetic: A single blood sample for HLA typing
Extracting of DNA from the blood sample using PCR-reaction
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.
Time frame: May 2017 - 2023
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Sechenov University