Atopic DermatitisNCT05090631
The Role of Genetic Factors in the Development of Atopic Dermatitis in the Kazakh Population
An observational study of Atopic Dermatitis, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial summary
This is a GWAS study that aims to identify possible candidate genes associate to atopic dermatitisby exploring single nucleotide polymorphism (SNP) in a group of atopic dermatitis, in the Kazakh population. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DNA analysis
- How many people
- 600 participants
- Where
- 1 siteKazakhstan
- Study dates
- 23 Oct 2021to 20 Jan 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: KAZAKH POPULATION
Who may be able to join
- Persons with various forms of a confirmed diagnosis of atopic dermatitis;
- The age of the patients is from 18 to 45+ years;
- Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.
- Persons who are able and willing to provide written informed consent;
- Persons capable and willing to comply with the research protocol;
Who cannot join
- Persons under the age of 18;
- Patients with severe concomitant systemic diseases, including cardiovascular, respiratory, hepatic and renal failure
- Patients with severe infectious processes (sepsis, abscess, hepatitis B and C, HIV)
- Persons with mental illness.
- Persons taking corticosteroid drugs, immunosuppressants within the last month;
- Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
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- Pregnant or lactating women;
- Tuberculosis of any localization in the active phase and in history;
- Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
- Severe and decompensated course of endocrine diseases;
- Autoimmune diseases;
- Systemic diseases;
- Oncological diseases;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventive and Personalized Medicine (2021-2023)
This is a GWAS study that aims to identify possible candidate genes associate to atopic dermatitisby exploring single nucleotide polymorphism (SNP) in a group of atopic dermatitis, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with atopic dermatitis
Read the detailed description
A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.
- Conditions
- Atopic Dermatitis
- Being tested
- DNA analysis
- Keywords
- GWAS
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
GWAS
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: | Patients with atopic dermatitis Receives: Genetic: DNA analysis | |
| Control group | Patients without atopic dermatitis Receives: Genetic: DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of SNPs associated with atopic dermatitis
Using GWAS to identify candidate genes associate with atopic dermatitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start23 Oct 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asfendiyarov Kazakh National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
- Investigators
- Gulya Sarybaeva, PhD, Principal investigator, Asfendiyarov Kazakh National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090631
- Sponsor's protocol ID
- 1196
- Status last verified
- Mar 2023
- First submitted
- 25 Sep 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive and Personalized Medicine (2021-2023)
- ClinicalTrials.gov ID
- NCT05090631
- Acronym / sponsor ID
- 1196
- Conditions
- Atopic Dermatitis
- Keywords
- GWAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 25 Oct 2021 (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.
This is a GWAS study that aims to identify possible candidate genes associate to atopic dermatitisby exploring single nucleotide polymorphism (SNP) in a group of atopic dermatitis, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with atopic dermatitis
Detailed description
A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | – | Genetic: DNA analysisPatients with atopic dermatitis |
| Control group | – | Genetic: DNA analysisPatients without atopic dermatitis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- KAZAKH POPULATION
Key inclusion criteria (5 listed)
- Persons with various forms of a confirmed diagnosis of atopic dermatitis;
- The age of the patients is from 18 to 45+ years;
- Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.
- Persons who are able and willing to provide written informed consent;
- Persons capable and willing to comply with the research protocol;
Key exclusion criteria (13 listed)
- Persons under the age of 18;
- Patients with severe concomitant systemic diseases, including cardiovascular, respiratory, hepatic and renal failure
- Patients with severe infectious processes (sepsis, abscess, hepatitis B and C, HIV)
- Persons with mental illness.
- Persons taking corticosteroid drugs, immunosuppressants within the last month;
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 |
|---|---|---|
| DNA analysisGWAS | Genetic | Control group, Experimental group: |
Primary outcome
number of SNPs associated with atopic dermatitis
Time frame: 1 year
Using GWAS to identify candidate genes associate with atopic dermatitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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.
Gulya Sarybaeva, PhD principal investigator
Asfendiyarov Kazakh National Medical University
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 Atopic Dermatitis, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 14 Mar 2023. 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 Kazakhstan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of SNPs associated with atopic dermatitis (time frame: 1 year). 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 14 Mar 2023.