Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-27 @ 8:48 AM
Study NCT ID:
NCT02212834
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2014-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surveillance Imaging Modalities for Breast Cancer Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wernli.k@ghc.org', 'phone': '206-287-2934', 'title': 'Karen J. Wernli, PhD', 'organization': 'Group Health Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was not a clinical trial. It was a cohort analysis of existing data.'}}, 'adverseEventsModule': {'description': 'This study was not a clinical trial. It was a cohort analysis, with no study intervention and no participant contact. Adverse events are not applicable.', 'eventGroups': [{'id': 'EG000', 'title': 'Mammograms', 'description': 'Surveillance mammograms in women with a personal history of breast cancer', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Breast MRI', 'description': 'Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Breast Cancers Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33,938', 'groupId': 'OG000'}, {'value': '2,506', 'groupId': 'OG001'}]}, {'units': 'exams', 'counts': [{'value': '33938', 'groupId': 'OG000'}, {'value': '2506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mammograms', 'description': 'Surveillance mammograms in women with a personal history of breast cancer'}, {'id': 'OG001', 'title': 'Breast MRI', 'description': 'Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post surveillance exam', 'description': 'Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI', 'unitOfMeasure': 'cancers detected', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'exams', 'denomUnitsSelected': 'exams'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mammograms', 'description': 'Surveillance mammograms in women with a personal history of breast cancer'}, {'id': 'FG001', 'title': 'Breast MRI', 'description': 'Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '33,938', 'numSubjects': '33938'}, {'groupId': 'FG001', 'numUnits': '2,506', 'numSubjects': '2506'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '33,938', 'numSubjects': '33938'}, {'groupId': 'FG001', 'numUnits': '2,506', 'numSubjects': '2506'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': 'NA', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': 'NA', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'exams', 'recruitmentDetails': 'Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012', 'preAssignmentDetails': 'Not a clinical trial. Analyses were conducted with the entire population who met study criteria. Unit of analysis was surveillance exam.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33,938', 'groupId': 'BG000'}, {'value': '2,506', 'groupId': 'BG001'}, {'value': '36444', 'groupId': 'BG002'}]}, {'units': 'surveillance exams', 'counts': [{'value': '33938', 'groupId': 'BG000'}, {'value': '2506', 'groupId': 'BG001'}, {'value': '36444', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mammograms', 'description': 'Surveillance mammograms in women with a personal history of breast cancer'}, {'id': 'BG001', 'title': 'Breast MRI', 'description': 'Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age at exam', 'categories': [{'title': '18 - 39 years', 'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}, {'title': '40 - 49 years', 'measurements': [{'value': '3,635', 'groupId': 'BG000'}, {'value': '574', 'groupId': 'BG001'}, {'value': '4209', 'groupId': 'BG002'}]}, {'title': '50 - 59 years', 'measurements': [{'value': '8,626', 'groupId': 'BG000'}, {'value': '1,005', 'groupId': 'BG001'}, {'value': '9631', 'groupId': 'BG002'}]}, {'title': '60 - 69 years', 'measurements': [{'value': '9,852', 'groupId': 'BG000'}, {'value': '632', 'groupId': 'BG001'}, {'value': '10484', 'groupId': 'BG002'}]}, {'title': '70 - 79 years', 'measurements': [{'value': '7,167', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '7300', 'groupId': 'BG002'}]}, {'title': '> or = 80 years', 'measurements': [{'value': '4,270', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4279', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'surveillance exams', 'denomUnitsSelected': 'surveillance exams'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33,938', 'groupId': 'BG000'}, {'value': '2,506', 'groupId': 'BG001'}, {'value': '36444', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'surveillance exams', 'denomUnitsSelected': 'surveillance exams'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity at time of exam', 'categories': [{'title': 'White, non-hispanic', 'measurements': [{'value': '26,717', 'groupId': 'BG000'}, {'value': '2,069', 'groupId': 'BG001'}, {'value': '28786', 'groupId': 'BG002'}]}, {'title': 'Black, non-hispanic', 'measurements': [{'value': '2,862', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '2924', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1,042', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '1109', 'groupId': 'BG002'}]}, {'title': 'Asian or Pacific Islander', 'measurements': [{'value': '2,583', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '2802', 'groupId': 'BG002'}]}, {'title': 'Mixed or Other', 'measurements': [{'value': '657', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '745', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'surveillance exams', 'denomUnitsSelected': 'surveillance exams'}], 'typeUnitsAnalyzed': 'surveillance exams', 'populationDescription': 'Characteristics at time of surveillance exam'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36444}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2014-03-21', 'resultsFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2014-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-13', 'studyFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Breast Cancers Detected', 'timeFrame': '12 months post surveillance exam', 'description': 'Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast', 'Cancer', 'Surveillance', 'Imaging', 'Comparative', 'Effectiveness'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29062507', 'type': 'BACKGROUND', 'citation': 'Johnson DS, Bush MT, Brandzel S, Wernli KJ. The patient voice in research-evolution of a role. Res Involv Engagem. 2016 Feb 22;2:6. doi: 10.1186/s40900-016-0020-4. eCollection 2016.'}, {'pmid': '31410813', 'type': 'BACKGROUND', 'citation': 'Henderson LM, Ichikawa L, Buist DSM, Lee JM, Bush M, Johnson D, Onega T, Nekhlyudov L, Kerlikowske K, Miglioretti DL, Sprague BL, Wernli KJ. Patterns of Breast Imaging Use Among Women with a Personal History of Breast Cancer. J Gen Intern Med. 2019 Oct;34(10):2098-2106. doi: 10.1007/s11606-019-05181-6. Epub 2019 Aug 13.'}, {'pmid': '31161975', 'type': 'RESULT', 'citation': 'Wernli KJ, Ichikawa L, Kerlikowske K, Buist DSM, Brandzel SD, Bush M, Johnson D, Henderson LM, Nekhlyudov L, Onega T, Sprague BL, Lee JM, Lehman CD, Miglioretti DL. Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. Radiology. 2019 Aug;292(2):311-318. doi: 10.1148/radiol.2019182475. Epub 2019 Jun 4.'}], 'seeAlsoLinks': [{'url': 'https://www.artefactgroup.com/work/simba-breast-cancer-decisions-aid/', 'label': 'SIMBA Decision tool'}, {'url': 'https://vimeo.com/154765251', 'label': 'Video of impact of patient engagement in research'}, {'url': 'https://www.bcsc-research.org/', 'label': 'Home page for the Breast Cancer Surveillance Consortium'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of surveillance breast MRI compared to mammography alone in women with a personal history of breast cancer', 'detailedDescription': "Our overall aim is to find out how well MRI works compared with mammography for surveillance in women who have previously had breast cancer. Specifically, our goals are to:\n\n1. Understand doctors' and patients' experiences with surveillance mammography and MRI\n2. Provide evidence on which outcomes are more or less likely to occur\n3. Develop patient decision aids to help women and their doctors choose the surveillance method that is right for them\n\nHow we will conduct the study: We will work with patients, doctors, policy makers, advocacy groups, and researchers to improve surveillance for women who have a personal history of breast cancer. Through focus groups with patients and interviews with doctors, we will gain insights into women's experience with surveillance mammography and MRI. We will also compare mammography to MRI using data from the Breast Cancer Surveillance Consortium-the largest collection of breast cancer surveillance data in the nation. We will use data from more than 13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each test works. We will measure the tests' effectiveness at finding second cancers, and estimate the likelihood of different outcomes. We will also determine whether one test appears to work better than the other to detect second breast cancers among different groups of women. We will then develop patient decision aids to help women and their doctors make more-informed choices about surveillance.\n\nWhat we hope to achieve: We hope this study will improve medical decision making and care for the 3 million women in the United States who have a history of breast cancer. Specifically, our results will help women and their doctors make clearer, better choices about the surveillance method that is right for them."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Surveillance imaging exams in women included in the Breast Cancer Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis between January 1, 2005 and December 31, 2012.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Surveillance imaging exams in women included in the Breast Cancer Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis between January 1, 2005 and December 31, 2012.\n\n\\-\n\nExclusion Criteria:\n\n* Women with a diagnosis of lobular carcinoma in situ\n* Women with missing cancer staging data from Surveillance, Epidemiology and End Results (SEER) Program records\n* Women with Stage 4 breast cancer at time of diagnosis\n* Women with a diagnosis of a second breast cancer event within six months of the primary diagnosis\n* Women who die within six months of primary diagnosis\n* Women who have had a double mastectomy'}, 'identificationModule': {'nctId': 'NCT02212834', 'acronym': 'SIMBA', 'briefTitle': 'Surveillance Imaging Modalities for Breast Cancer Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'CE-1304-6656'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mammograms', 'description': 'Surveillance mammograms in women with a personal history of breast cancer'}, {'label': 'Breast MRI', 'description': 'Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karen J. Wernli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Group Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dartmouth College', 'class': 'OTHER'}, {'name': 'Harvard Pilgrim Health Care', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}