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Brief Title: Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study
Official Title: Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density
Study ID: NCT02980848
Brief Summary: This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.
Detailed Description: Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI) by extent of breast density. Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of experience, and whether any "learning curve" depends on radiologist specialty (i.e., breast imaging specialist vs. general radiologist). Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive breast cancer. Covid-19 Enhancement Aim and Hypotheses: Develop patient-focused messaging content through focus groups that radiology facilities can use when scheduling appointments to inform women of the safety to schedule or postpone breast screening or diagnostic services.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Sacramento Area Breast Imaging Registry, Davis, California, United States
San Francisco Mammography Registry, San Francisco, California, United States
Metro Chicago Breast Cancer Registry, Chicago, Illinois, United States
New Hampshire Mammography Network, Lebanon, New Hampshire, United States
Carolina Mammography Registry, Chapel Hill, North Carolina, United States
Vermont Breast Cancer Surveillance System, Burlington, Vermont, United States
Kaiser Permanente Washington Breast Cancer Surveillance Registry, Seattle, Washington, United States
Name: Diana L Miglioretti, PhD
Affiliation: University of California, Davis
Role: PRINCIPAL_INVESTIGATOR