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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Harvard Pilgrim Health Care | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| University of California, San Francisco |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mammograms | Surveillance mammograms in women with a personal history of breast cancer | ||
| Breast MRI | Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Breast Cancers Detected | Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI | 12 months post surveillance exam |
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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:
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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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| Name | Affiliation | Role |
|---|---|---|
| Karen J. Wernli, PhD | Group Health Research Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29062507 | Background | 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. | |
| 31410813 | Background | 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. |
| Label | URL |
|---|---|
| SIMBA Decision tool | View source |
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Not a clinical trial. Analyses were conducted with the entire population who met study criteria. Unit of analysis was surveillance exam.
Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012
| ID | Title | Description |
|---|---|---|
| FG000 | Mammograms | Surveillance mammograms in women with a personal history of breast cancer |
| FG001 | Breast MRI | Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Characteristics at time of surveillance exam
| ID | Title | Description |
|---|---|---|
| BG000 | Mammograms | Surveillance mammograms in women with a personal history of breast cancer |
| BG001 | Breast MRI | Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Breast Cancers Detected | Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI | Posted | Number | cancers detected | 12 months post surveillance exam | exams | exams |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mammograms | Surveillance mammograms in women with a personal history of breast cancer |
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This study was not a clinical trial. It was a cohort analysis of existing data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen J. Wernli, PhD | Group Health Research Institute | 206-287-2934 | wernli.k@ghc.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
| University of Wisconsin, Madison | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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| 31161975 | Result | 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. |
| Video of impact of patient engagement in research | View source |
| Home page for the Breast Cancer Surveillance Consortium | View source |
| BG002 | Total | Total of all reporting groups |
| surveillance exams |
|
| surveillance exams |
| surveillance exams |
|
| Sex: Female, Male | Count of Units | surveillance exams | surveillance exams |
|
| Race/Ethnicity, Customized | Count of Units | surveillance exams | surveillance exams |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| exams |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Breast MRI | Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer | 0 | 0 | 0 | 0 |
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