Idiopathic OsteoarthritisNCT05095142
The Role of Genetic Factors in the Development of Idiopathic Osteoarthritis of the Knee in the Kazakh Population
An observational study of Idiopathic Osteoarthritis, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial summary
The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Idiopathic Osteoarthritis
- What is being tested?
- SNP analysis of the DNA
- How many people
- 500 participants
- Where
- 1 siteKazakhstan
- Study dates
- 30 Mar 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 18 to 68 years
- All sexes
- Adult, Older adult
Study population: Persons of Kazakh nationality
Who may be able to join
- Patients with bilateral idiopathic gonarthrosis aged 18 to 65 years;
- Representatives of the Kazakh ethnic group up to the 3rd generation;
- Hereditary history of arthrosis;
- Persons who are able and willing to provide written informed consent;
Who cannot join
- Patients with bilateral idiopathic gonarthrosis under 18 years of age and over 65 years of age;
- Representatives of other ethnic groups;
- Representatives of the Kazakh ethnic group less than 3 generations;
- No family history of bilateral idiopathic gonarthrosis;
- Patients with an acute period of the inflammatory process (laboratory and clinical signs);
- 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.
Kazakhstan1 site
Scientific center of traumatology and orthopedics named after academician Batpenova ND
Almaty
About this study
Official title: Preventive and Personalized Medicine (2021-2023)
The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee
- Conditions
- Idiopathic Osteoarthritis
- Being tested
- SNP analysis of the DNA
- Keywords
- SNP
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 idiopathic osteoarthritis of the knee Receives: Genetic: SNP analysis of the DNA | |
| Control group | patients without idiopathic osteoarthritis of the knee Receives: Genetic: SNP analysis of the DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
enotyping for the SNP associated with liver cirrhosis
Genotype frequency of SNP in the study genes of participants and control participants.
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 posted27 Oct 2021
- Study start30 Mar 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 Idiopathic OsteoarthritisStudies 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
- 500 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
- Olzhas Bekarisov, PhD, Principal investigator, Scientific center of traumatology and orthopedics named after academician Batpenova ND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095142
- Sponsor's protocol ID
- 1191
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 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
- NCT05095142
- Acronym / sponsor ID
- 1191
- Conditions
- Idiopathic Osteoarthritis
- Keywords
- SNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 27 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.
The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | – | Genetic: SNP analysis of the DNApatients with idiopathic osteoarthritis of the knee |
| Control group | – | Genetic: SNP analysis of the DNApatients without idiopathic osteoarthritis of the knee |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Persons of Kazakh nationality
Key inclusion criteria (4 listed)
- Patients with bilateral idiopathic gonarthrosis aged 18 to 65 years;
- Representatives of the Kazakh ethnic group up to the 3rd generation;
- Hereditary history of arthrosis;
- Persons who are able and willing to provide written informed consent;
Key exclusion criteria (13 listed)
- Patients with bilateral idiopathic gonarthrosis under 18 years of age and over 65 years of age;
- Representatives of other ethnic groups;
- Representatives of the Kazakh ethnic group less than 3 generations;
- No family history of bilateral idiopathic gonarthrosis;
- Patients with an acute period of the inflammatory process (laboratory and clinical signs);
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
enotyping for the SNP associated with liver cirrhosis
Time frame: 1 year
Genotype frequency of SNP in the study genes of participants and control participants.
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.
Olzhas Bekarisov, PhD principal investigator
Scientific center of traumatology and orthopedics named after academician Batpenova ND
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 Idiopathic Osteoarthritis, 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 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?
enotyping for the SNP associated with liver cirrhosis (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.