Liver CirrhosisNCT05095181
To Study the Effects of Host Genetic Factors on Liver Cirrhosis
An observational study of Liver Cirrhosis, 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 liver cirrhosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- SNP analysis of the DNA
- How many people
- 1,000 participants
- Where
- 1 siteKazakhstan
- Study dates
- 29 Mar 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 60 years
- All sexes
- Adult
Study population: KAZAKH POPULATION
Who may be able to join
- hepatitis B
Who cannot join
- the casual aget of liver disease is not viral infection, such as alcohol abuse
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
National Scientific Center of Surgery named after A.N. Syzganova
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 liver cirrhosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis .
- Conditions
- Liver Cirrhosis
- Being tested
- SNP analysis of the DNA
- Keywords
- SNP
- Medical subject headings
- Liver Cirrhosis
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 liver cirrhosis Receives: Genetic: SNP analysis of the DNA | |
| Control group | patients without liver cirrhosis Receives: Genetic: SNP analysis of the DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
genotyping 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 start29 Mar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- 1,000 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
- Bibigul Saparbekovna, PhD, Principal investigator, JSC "National Scientific Center of Surgery named after A.N. Syzganova "
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095181
- Sponsor's protocol ID
- 1188
- 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
- Individual data sharing
- Undecided
Publications
Ilyassova BS, Abzhaparova B, Smailova DS, Bolatov A, Baymakhanov B, Beloussov V, Solomadin M, Shamsivaliyeva K, Alpysbayava G, Issakova G, Granica J, Mukushkina D, Sagatov IY, Kaniyev S. Prevalence and genotypes distribution of virus hepatitis B and hepatitis delta virus in chronic liver diseases in Kazakhstan. BMC Infect Dis. 2023 Aug 14;23(1):533. doi: 10.1186/s12879-023-08524-1.
PubMed 37580657
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
- NCT05095181
- Acronym / sponsor ID
- 1188
- Conditions
- Liver Cirrhosis
- Keywords
- SNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (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 liver cirrhosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | – | Genetic: SNP analysis of the DNApatients with liver cirrhosis |
| Control group | – | Genetic: SNP analysis of the DNApatients without liver cirrhosis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- KAZAKH POPULATION
Key inclusion criteria (1 listed)
- hepatitis B
Key exclusion criteria (1 listed)
- the casual aget of liver disease is not viral infection, such as alcohol abuse
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
genotyping 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.
- Derived from this study: PubMed 37580657Ilyassova BS, Abzhaparova B, Smailova DS, Bolatov A, Baymakhanov B, Beloussov V, Solomadin M, Shamsivaliyeva K, Alpysbayava G, Issakova G, Granica J, Mukushkina D, Sagatov IY, Kaniyev S. Prevalence and genotypes distribution of virus hepatitis B and hepatitis delta virus in chronic liver diseases in Kazakhstan. BMC Infect Dis. 2023 Aug 14;23(1):533. doi: 10.1186/s12879-023-08524-1.
- 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.
Bibigul Saparbekovna, PhD principal investigator
JSC "National Scientific Center of Surgery named after A.N. Syzganova "
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 Liver Cirrhosis, 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 1 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: 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?
genotyping 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?
On the ClinicalTrials.gov record for NCT05095181, which also lists 1 linked publication.
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.