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OpenTrials
Completed

NCT Number: NCT02212834

Surveillance Imaging Modalities for Breast Cancer Assessment

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Dartmouth College
  • Harvard Pilgrim Health Care
  • Patient-Centered Outcomes Research Institute
  • University of California, San Francisco
  • University of North Carolina, Chapel Hill
  • University of Wisconsin, Madison

Registry information

Official study title

Comparative Effectiveness of Surveillance Modalities in Breast Cancer Survivors

Acronym: SIMBA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2014
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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