NCT05090605

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

September 25, 2021

Last Update Submit

March 13, 2023

Conditions

Keywords

GWAS

Outcome Measures

Primary Outcomes (1)

  • number of SNPs associated with breast cancer

    Using GWAS to identify candidate genes associate with breast cancer

    1 year

Study Arms (2)

Experimental group:

Patients with breast cancer

Genetic: DNA analysis

Control group

Patients without breast cancer

Genetic: DNA analysis

Interventions

GWAS

Control groupExperimental group:

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

in a group of breast cancer, in the Kazakh population

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

JSC "Kazakh Institute of Oncology and Radiology"

Almaty, 050000, Kazakhstan

Location

JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan

Almaty, Kazakhstan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dilyara Radikovna Kaidarova, M.D, Prof., Academician of the

    JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan

    STUDY DIRECTOR
  • Nazgul Omarbayeva, M.D / PhD

    JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Experimental Medicine

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 25, 2021

Study Start

March 30, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations