Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-31 @ 7:55 PM
Study NCT ID:
NCT05090605
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2021-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Genetic Factors in the Development of Breast Cancer in the Kazakh Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2021-09-25', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of SNPs associated with breast cancer', 'timeFrame': '1 year', 'description': 'Using GWAS to identify candidate genes associate with breast cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GWAS'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'in a group of breast cancer, in the Kazakh population', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons with a histologically confirmed diagnosis of breast cancer.\n* The age of patients is from 18 to 60 years;\n* Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.\n* Persons who are able and willing to provide written informed consent;\n* Persons capable and willing to comply with the research protocol;\n\nExclusion Criteria:\n\n* Persons under 18 and over 60 years old;\n* Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;\n* Pregnant or lactating women;\n* Tuberculosis of any localization in the active phase and in history;\n* Severe and decompensated diseases of the liver and kidneys, cardiovascular system;\n* Severe and decompensated course of endocrine diseases;\n* Lack of histological verification of breast tumor'}, 'identificationModule': {'nctId': 'NCT05090605', 'briefTitle': 'The Role of Genetic Factors in the Development of Breast Cancer in the Kazakh Population', 'organization': {'class': 'OTHER', 'fullName': 'Asfendiyarov Kazakh National Medical University'}, 'officialTitle': 'Preventive and Personalized Medicine (2021-2023)', 'orgStudyIdInfo': {'id': '1186'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group:', 'description': 'Patients with breast cancer', 'interventionNames': ['Genetic: DNA analysis']}, {'label': 'Control group', 'description': 'Patients without breast cancer', 'interventionNames': ['Genetic: DNA analysis']}], 'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC', 'description': 'GWAS', 'armGroupLabels': ['Control group', 'Experimental group:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'JSC "Kazakh Institute of Oncology and Radiology"', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}], 'overallOfficials': [{'name': 'Dilyara Radikovna Kaidarova, M.D, Prof., Academician of the', 'role': 'STUDY_DIRECTOR', 'affiliation': 'JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan'}, {'name': 'Nazgul Omarbayeva, M.D / PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JSC "Kazakh Institute of Oncology and Radiology", Almaty, Kazakhstan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asfendiyarov Kazakh National Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Laboratory of Experimental Medicine', 'investigatorFullName': 'Ildar Fakhradiyev', 'investigatorAffiliation': 'Asfendiyarov Kazakh National Medical University'}}}}