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Surveillance Imaging Modalities for Breast Cancer Assessment (SIMBA)

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ClinicalTrials.gov Identifier: NCT02212834
Recruitment Status : Completed
First Posted : August 8, 2014
Results First Posted : February 7, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
Dartmouth College
Harvard Pilgrim Health Care
University of North Carolina, Chapel Hill
University of California, San Francisco
University of Wisconsin, Madison
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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

Condition or disease
Breast Cancer

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:

  1. Understand doctors' and patients' experiences with surveillance mammography and MRI
  2. Provide evidence on which outcomes are more or less likely to occur
  3. 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.


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Study Type : Observational
Actual Enrollment : 36444 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors
Study Start Date : October 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Number of Breast Cancers Detected [ Time Frame: 12 months post surveillance exam ]
    Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212834


Sponsors and Collaborators
Kaiser Permanente
Dartmouth College
Harvard Pilgrim Health Care
University of North Carolina, Chapel Hill
University of California, San Francisco
University of Wisconsin, Madison
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Karen J. Wernli, PhD Group Health Research Institute

Additional Information:
Publications:
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02212834     History of Changes
Other Study ID Numbers: CE-1304-6656
First Posted: August 8, 2014    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kaiser Permanente:
Breast
Cancer
Surveillance
Imaging
Comparative
Effectiveness
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases