- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095129
The Role of Genetic Factors in the Development of Idiopathic Scoliosis in the Kazakh Population
March 13, 2023 updated by: Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
Preventive and Personalized Medicine (2021-2023)
The purpose of this study is to identify genetic determinants of susceptibility to idiopathic scoliosis .
It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic scoliosis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Almaty, Kazakhstan
- Scientific center of traumatology and orthopedics named after academician Batpenova ND
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Persons of Kazakh nationality
Description
Inclusion Criteria:
- Persons with a doctor-confirmed diagnosis of idiopathic scoliosis;
- Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
- Hereditary history of scoliosis;
- Persons who are able and willing to provide written informed consent;
Exclusion Criteria:
- Patients diagnosed with idiopathic scoliosis under 4 and over 40 years of age;
- Representatives of the Kazakh ethnic group less than 3 generations;
- No family history of bilateral idiopathic scoliosis;
- 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;
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Experimental group:
patients with idiopathic scoliosis
|
SNP analysis of the DNA obtained from peripheral blood sample
|
|
Control group
patients without idiopathic scoliosis
|
SNP analysis of the DNA obtained from peripheral blood sample
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
October 21, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
October 27, 2021
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Scoliosis
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Istituto Scientifico Italiano Colonna VertebraleActive, not recruitingAdolescent Idiopathic Scoliosis (AIS) | Juvenile Idiopathic ScoliosisItaly
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