Bronchial AsthmaNCT05088512
The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population
An observational study of Bronchial Asthma and Genome Wide Association Studies, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial summary
To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Bronchial Asthma, Genome Wide Association Studies
- What is being tested?
- SNP analysis of the DNA
- How many people
- 300 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons with bronchial asthma confirmed by a doctor
Who may be able to join
- Persons with bronchial asthma confirmed by a doctor;
- The age of the patients is from 5 to 60 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 who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
- 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)
To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed.
Read the detailed description
Unrelated Kazaks subjects who have bronchial asthma were recruited in the current study. Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with bronchial asthma and normal control subjects free of bronchial asthma
- Conditions
- Bronchial Asthma, Genome Wide Association Studies
- Being tested
- SNP analysis of the DNA
- Keywords
- Bronchial Asthma, Genome Wide Association Studies
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP analysis of the DNAGenetic
SNP analysis of the DNA obtained from peripheral blood sample
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: | Patients with bronchial asthma Receives: Genetic: SNP analysis of the DNA | |
| Control group | Patients without bronchial asthma Receives: Genetic: SNP analysis of the DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of SNPs associated with bronchial asthma
Using SNPsto identify candidate genes associate with bronchial asthma
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 posted22 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 Bronchial AsthmaStudies 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
- 300 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088512
- Sponsor's protocol ID
- 1207
- 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
- Individual data sharing
- Undecided
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
- NCT05088512
- Acronym / sponsor ID
- 1207
- Conditions
- Bronchial Asthma, Genome Wide Association Studies
- Keywords
- Bronchial Asthma, Genome Wide Association Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 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
- 22 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.
To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed.
Detailed description
Unrelated Kazaks subjects who have bronchial asthma were recruited in the current study. Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with bronchial asthma and normal control subjects free of bronchial asthma
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | – | Genetic: SNP analysis of the DNAPatients with bronchial asthma |
| Control group | – | Genetic: SNP analysis of the DNAPatients without bronchial asthma |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with bronchial asthma confirmed by a doctor
Key inclusion criteria (5 listed)
- Persons with bronchial asthma confirmed by a doctor;
- The age of the patients is from 5 to 60 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 (8 listed)
- Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
- 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;
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 |
|---|---|---|
| SNP analysis of the DNASNP analysis of the DNA obtained from peripheral blood sample | Genetic | Control group, Experimental group: |
Primary outcome
number of SNPs associated with bronchial asthma
Time frame: 1 year
Using SNPsto identify candidate genes associate with bronchial asthma
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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchial Asthma and Genome Wide Association Studies, 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 8 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 bronchial asthma (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.