Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT03989258
Status:
UNKNOWN
Last Update Posted:
2019-06-20
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalised Risk-based Breast Cancer Prevention and Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000096442', 'term': 'Genetic Risk Score'}], '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'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28389}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women in the population with genetically higher risk for breast cancer', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Number of screen-detected breast cancers in different risk groups', 'timeFrame': '3-years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Screening', 'Genetic risk', 'Polygenic risk score'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCohort 1:\n\n* Available NGS (WGS or WES) data for detection of breast cancer moderate to high genetic risk variants in BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;\n* Available genetic (WGS, genotyping) data for PRS calculation, participants in age 40-74 will be further selected;\n\nCohort 2:\n\n* Available genotyping data;\n* No available NGS data for BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;\n* Participants in the age group 40-74 with available genetic data for PRS calculation;\n\nCohort StMG:\n\n• Female participants in Estonian Biobank in the age group 50-69 participating at least once in the current Estonian population-based screening program during 2016-2020.\n\nExclusion Criteria:\n\nCohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.'}, 'identificationModule': {'nctId': 'NCT03989258', 'briefTitle': 'Personalised Risk-based Breast Cancer Prevention and Screening', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'Implementation of a Model for Personalised Risk-Based Breast Cancer Prevention and Screening', 'orgStudyIdInfo': {'id': 'estPerMed 1, Breast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1', 'description': 'High monogenic breast cancer risk', 'interventionNames': ['Diagnostic Test: Mammography outside official screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2', 'description': 'High polygenic breast cancer risk', 'interventionNames': ['Diagnostic Test: Mammography outside official screening']}, {'type': 'NO_INTERVENTION', 'label': 'Cohort StMG', 'description': 'Standard mammography screening in age 50-69'}], 'interventions': [{'name': 'Mammography outside official screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'Radiologic study', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'state': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Peeter Padrik, MD, PhD', 'role': 'CONTACT', 'email': 'peeter.padrik@kliinikum.ee', 'phone': '+3727319800'}], 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '13419', 'city': 'Tallinn', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Vahur Valvere, MD,PhD', 'role': 'CONTACT', 'email': 'vahur.valvere@regionaalhaigla.ee', 'phone': '+3726172304'}], 'facility': 'The North Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tartu', 'class': 'OTHER'}, {'name': 'North Estonia Medical Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Cancer Center', 'investigatorFullName': 'Peeter Padrik', 'investigatorAffiliation': 'Tartu University Hospital'}}}}