An observational study in Breast Cancer, sponsored by Kaiser Permanente. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Kaiser Permanente · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 36,444 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
Surveillance mammograms in women with a personal history of breast cancer
Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
Number of Breast Cancers Detected
Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI
Time frame: 12 months post surveillance exam
Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012
| Milestone | Mammograms | Breast MRI |
|---|---|---|
| Started | 33938 | 2506 |
| Completed | 33938 | 2506 |
| Not completed | 0 | 0 |
Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI
| cancers detected | Mammograms | Breast MRI |
|---|---|---|
| Number of Breast Cancers Detected | 279 | 27 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mammograms | — | — | — |
| Breast MRI | — | — | — |
Characteristics at time of surveillance exam
| Age, Customized(surveillance exams) | Mammograms | Breast MRI | Total |
|---|---|---|---|
| Age at exam — 18 - 39 years | 388 | 153 | 541 |
| Age at exam — 40 - 49 years | 3,635 | 574 | 4209 |
| Age at exam — 50 - 59 years | 8,626 | 1,005 | 9631 |
| Age at exam — 60 - 69 years | 9,852 | 632 | 10484 |
| Age at exam — 70 - 79 years | 7,167 | 133 | 7300 |
| Age at exam — > or = 80 years | 4,270 | 9 | 4279 |
| Sex: Female, Male(surveillance exams) | Mammograms | Breast MRI | Total |
|---|---|---|---|
| Female | 33,938 | 2,506 | 36444 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(surveillance exams) | Mammograms | Breast MRI | Total |
|---|---|---|---|
| Race/ethnicity at time of exam — White, non-hispanic | 26,717 | 2,069 | 28786 |
| Race/ethnicity at time of exam — Black, non-hispanic | 2,862 | 62 | 2924 |
| Race/ethnicity at time of exam — Hispanic | 1,042 | 67 | 1109 |
| Race/ethnicity at time of exam — Asian or Pacific Islander | 2,583 | 219 | 2802 |
| Race/ethnicity at time of exam — Mixed or Other | 657 | 88 | 745 |
| Race/ethnicity at time of exam — Missing | 77 | 1 | 78 |
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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