- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02212834
Surveillance Imaging Modalities for Breast Cancer Assessment (SIMBA)
Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors
Study Overview
Status
Conditions
Detailed Description
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:
- Understand doctors' and patients' experiences with surveillance mammography and MRI
- Provide evidence on which outcomes are more or less likely to occur
- Develop patient decision aids to help women and their doctors choose the surveillance method that is right for them
How 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.
What 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
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Exclusion Criteria:
- Women with a diagnosis of lobular carcinoma in situ
- Women with missing cancer staging data from Surveillance, Epidemiology and End Results (SEER) Program records
- Women with Stage 4 breast cancer at time of diagnosis
- Women with a diagnosis of a second breast cancer event within six months of the primary diagnosis
- Women who die within six months of primary diagnosis
- Women who have had a double mastectomy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Mammograms
Surveillance mammograms in women with a personal history of breast cancer
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Breast MRI
Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Breast Cancers Detected
Time Frame: 12 months post surveillance exam
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Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI
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12 months post surveillance exam
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen J. Wernli, PhD, Group Health Research Institute
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE-1304-6656
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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