PemphigusNCT05284929
Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
An observational study of Pemphigus and Bullous Pemphigoid, run by Sechenov University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pemphigus, Bullous Pemphigoid, Stevens-Johnson Syndrome
- What is being tested?
- A single blood sample for HLA typing
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 17 May 2017to 17 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Signed informed consent
- Age of patients >18 years
- Confirmed diagnosis
Who cannot join
- No as pemphigus is a life-threatening condition
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Sechenov University
Moscow, 119991
Anfisa Lepekhova, PhD, +79035433074, anfisa.lepehova@yandex.ru
About this study
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.
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.
Read more
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.
- Being tested
- A single blood sample for HLA typing
- Medical subject headings
- Pemphigus, Pemphigoid, Bullous, Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single blood sample for HLA typingGenetic
Extracting of DNA from the blood sample using PCR-reaction
| Study group | Role | What they receive |
|---|---|---|
| Patients with pemphigus | Not described Receives: Genetic: A single blood sample for HLA typing | |
| Healthy controls | Not described Receives: Genetic: A single blood sample for HLA typing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: May 2017 - 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start17 May 2017
- Primary completion17 Nov 2022 (estimated)
- Study completion17 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sechenov University
- Sponsor type
- University, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284929
- Sponsor's protocol ID
- #03-22
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05284929
- Acronym / sponsor ID
- #03-22
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sechenov UniversityUniversity, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- 17 May 2017 (actual)
- Primary completion
- 17 Nov 2022 (estimated)
- Study completion
- 17 Mar 2023 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pemphigus | – | Genetic: A single blood sample for HLA typing |
| Healthy controls | – | Genetic: A single blood sample for HLA typing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Signed informed consent
- Age of patients >18 years
- Confirmed diagnosis
Key exclusion criteria (1 listed)
- No as pemphigus is a life-threatening condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A single blood sample for HLA typingExtracting of DNA from the blood sample using PCR-reaction | Genetic | Healthy controls, Patients with pemphigus |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus and Bullous Pemphigoid, run by Sechenov University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of HLA-DRB1 and HLA-DQB1 alleles frequencies in PV patients and controls (time frame: May 2017 - 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.