Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT04920656
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2021-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer
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': 'Peripheral blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed breast cancer patients tested by universal multigene panel testing or guideline-based targeted testing', 'timeFrame': '2021-2023'}, {'measure': 'Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing', 'timeFrame': '2021-2023'}, {'measure': 'The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients', 'timeFrame': '2021-2023'}], 'secondaryOutcomes': [{'measure': 'Rate of cascade testing of family members of the participants with positive pathogenic mutation', 'timeFrame': '2021-2023', 'description': 'The family of the positive patients will be offered the genetic testing.'}, {'measure': 'Prevalence of pathogenic or likely pathogenic mutations among family members of the patients with pathogenic mutations using the universal multigene panel', 'timeFrame': '2021-2023'}, {'measure': 'Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing', 'timeFrame': '2021-2023'}, {'measure': 'The reasons/ Barriers for refusal of genetic cascade testing among family members of the tested patients with pathogenic mutations', 'timeFrame': '2021-2023'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients who fulfill the inclusion/exclusion criteria, and are treated and followed up at KHCC will be invited.\n\nA total of 1000 patients are estimated to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, age ≥ 18 years at time of cancer diagnosis\n* Pathology proven diagnosis of breast cancer (including DCIS); any stage. (prior history of cancer is allowed)\n* Willingness to participate\n* Signed consent form.\n\nExclusion Criteria:\n\n\\- Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications'}, 'identificationModule': {'nctId': 'NCT04920656', 'briefTitle': 'Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'King Hussein Cancer Center'}, 'officialTitle': 'Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer', 'orgStudyIdInfo': {'id': '20 KHCC 202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients', 'description': 'All adult patients with a confirmed diagnosis of breast cancer, aged 18 or older at time of cancer diagnosis, will be invited to participate.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11941', 'city': 'Amman', 'state': 'Amman Governorate', 'country': 'Jordan', 'facility': 'King Hussein Cancer Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Hikmat Abdel-Razeq', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Hussein Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Hussein Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General', 'investigatorFullName': 'Hikmat Abdel-Razeq', 'investigatorAffiliation': 'King Hussein Cancer Center'}}}}