- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05090605
The Role of Genetic Factors in the Development of Breast Cancer in the Kazakh Population
March 13, 2023 updated by: Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
Preventive and Personalized Medicine (2021-2023)
This is a GWAS study that aims to identify possible candidate genes associate to breast cancer by exploring single nucleotide polymorphism (SNP) in a group of breast cancer, 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 breast cancer
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
700
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, 050000
- JSC "Kazakh Institute of Oncology and Radiology"
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Almaty, Kazakhstan
- JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan
-
-
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
in a group of breast cancer, in the Kazakh population
Description
Inclusion Criteria:
- Persons with a histologically confirmed diagnosis of breast cancer.
- The age of patients is from 18 to 60 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 18 and over 60 years old;
- 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;
- Lack of histological verification of breast tumor
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental group:
Patients with breast cancer
|
GWAS
|
|
Control group
Patients without breast cancer
|
GWAS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of SNPs associated with breast cancer
Time Frame: 1 year
|
Using GWAS to identify candidate genes associate with breast cancer
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dilyara Radikovna Kaidarova, M.D, Prof., Academician of the, JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan
- Principal Investigator: Nazgul Omarbayeva, M.D / PhD, JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan
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 30, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
September 25, 2021
First Submitted That Met QC Criteria
October 21, 2021
First Posted (Actual)
October 25, 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
- 1186
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.
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