EpilepsyNCT05088499
The Role of Genetic Factors in the Development of Epilepsy in the Kazakh Population
An observational study of Epilepsy, 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 epilepsy by exploring single nucleotide polymorphism (SNP) in a group of epilepsy, in the Kazakh population. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- DNA analysis
- How many people
- 600 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Feb 2022to 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 0 to 5 years
- All sexes
- Child
Study population: Children of Kazakh ethnic group
Who may be able to join
- Children with seizures, confirmed by EEG and no morphological damage to the brain, confirmed by MRI of the brain;
- The age of the patients is from 0 to 5 years;
- Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
- Children are parents or legal guardians who have given written informed consent.
Who cannot join
- Children over 5 years old;
- Children whose parents, according to the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
- Children with seizures with brain damage that cause epilepsy;
- Children of a non-Kazakh ethnic group.
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 epilepsy by exploring single nucleotide polymorphism (SNP) in a group of epilepsy, 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 epilepsy
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
- Epilepsy
- Being tested
- DNA analysis
- Keywords
- GWAS
- Medical subject headings
- Epilepsy
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 epilepsy Receives: Genetic: DNA analysis | |
| Control group | Patients without epilepsy 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 epilepsy
Using GWAS to identify candidate genes associate with epilepsy
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 start1 Feb 2022
- 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 EpilepsyStudies 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
- Altynshash Jaxybayeva, Study director, Astana Medical University, Nur-Sultan, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088499
- Sponsor's protocol ID
- 1199
- Status last verified
- Mar 2023
- First submitted
- 25 Sep 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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
- NCT05088499
- Acronym / sponsor ID
- 1199
- Conditions
- Epilepsy
- Keywords
- GWAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (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.
This is a GWAS study that aims to identify possible candidate genes associate to epilepsy by exploring single nucleotide polymorphism (SNP) in a group of epilepsy, 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 epilepsy
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 epilepsy |
| Control group | – | Genetic: DNA analysisPatients without epilepsy |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- Children of Kazakh ethnic group
Key inclusion criteria (4 listed)
- Children with seizures, confirmed by EEG and no morphological damage to the brain, confirmed by MRI of the brain;
- The age of the patients is from 0 to 5 years;
- Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
- Children are parents or legal guardians who have given written informed consent.
Key exclusion criteria (4 listed)
- Children over 5 years old;
- Children whose parents, according to the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
- Children with seizures with brain damage that cause epilepsy;
- Children of a non-Kazakh ethnic group.
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 epilepsy
Time frame: 1 year
Using GWAS to identify candidate genes associate with epilepsy
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.
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Altynshash Jaxybayeva study director
Astana Medical University, Nur-Sultan, Kazakhstan
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 Epilepsy, 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 4 inclusion and 4 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 epilepsy (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.