The Role of Genetic Factors in the Development of Idiopat... | NCT05095129

Studies
The Role of Genetic Factors in the Development of Idiopathic Scoliosis in the Kazakh Population

NCT05095129

Sponsor

Asfendiyarov Kazakh National Medical University

Status

Completed

Last Update Posted

Mar 14, 2023Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Idiopathic Scoliosis

Interventions

SNP analysis of the DNA

Countries

Kazakhstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2022Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Oct 21, 2021

First Submission Date that Met QC Criteria

Oct 26, 2021

First Posted Date

Oct 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2023

Last Update Posted Date

Mar 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ildar Fakhradiyev, Head of the Laboratory of Experimental Medicine, Asfendiyarov Kazakh National Medical UniversityPrincipal Investigator

Lead Sponsor

Asfendiyarov Kazakh National Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group:		patients with idiopathic scoliosis	Genetic: SNP analysis of the DNA
Control group		patients without idiopathic scoliosis	Genetic: SNP analysis of the DNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SNP analysis of the DNA	Genetic	SNP analysis of the DNA obtained from peripheral blood sample	Control group Experimental group:

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genotyping for the SNP associated with liver cirrhosis	Genotype frequency of SNP in the study genes of participants and control participants.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Persons of Kazakh nationality

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oljas Bekarïsov, PhD	Scientific center of traumatology and orthopedics named after academician Batpenova ND	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scientific center of traumatology and orthopedics named after academician Batpenova ND		Almaty			Kazakhstan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided