The Role of Genetic Factors in the Development of Atopic... | NCT05090631

Studies
The Role of Genetic Factors in the Development of Atopic Dermatitis in the Kazakh Population

NCT05090631

Sponsor

Asfendiyarov Kazakh National Medical University

Status

Completed

Last Update Posted

Mar 14, 2023Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

DNA analysis

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

Oct 23, 2021Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Sep 25, 2021

First Submission Date that Met QC Criteria

Oct 21, 2021

First Posted Date

Oct 25, 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

This is a GWAS study that aims to identify possible candidate genes associate to atopic dermatitisby exploring single nucleotide polymorphism (SNP) in a group of atopic dermatitis, 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 atopic dermatitis

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.

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group:		Patients with atopic dermatitis	Genetic: DNA analysis
Control group		Patients without atopic dermatitis	Genetic: DNA analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic	GWAS	Control group Experimental group:

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of SNPs associated with atopic dermatitis	Using GWAS to identify candidate genes associate with atopic dermatitis	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons with various forms of a confirmed diagnosis of atopic dermatitis;
The age of the patients is from 18 to 45+ years;
Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.
Persons who are able and willing to provide written informed consent;
Persons capable and willing to comply with the research protocol;

Exclusion Criteria:

Persons under the age of 18;
Patients with severe concomitant systemic diseases, including cardiovascular, respiratory, hepatic and renal failure
Patients with severe infectious processes (sepsis, abscess, hepatitis B and C, HIV)
Persons with mental illness.
Persons taking corticosteroid drugs, immunosuppressants within the last month;
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

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

KAZAKH POPULATION

Sampling Method

Probability Sample

Name	Affiliation	Role
Gulya Sarybaeva, PhD	Asfendiyarov Kazakh National Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kazakhstan		Almaty		050020	Kazakhstan

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

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