Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study
Status unconfirmed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02980848
- Run by
- University of California, Davis
- People needed
- 1341172
- Starts
- 2016-09-01
- Expected to finish
- 2022-02-01
- Last updated by the study team
- 2021-11-17
Who can join
Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged 40-79 undergoing screening mammography from 2010-2017 for comparisons with tomosynthesis and 2005-2017 for comparison with breast MRI at a facility that participates in one of six BCSC breast imaging registries
- Digital mammography exams performed for screening and performed with or without supplemental screening with digital breast tomosynthesis from 2010-2017 or breast MRI from 2005-2017, at a facility that participates in one of seven BCSC breast imaging registries, and in women who meet inclusion criteria.
You may not qualify if…
- Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation.
- Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
- Exams without complete cancer capture during the follow-up period
- Aim 1 Patient Reported Outcomes
- Inclusion criteria:
- Women aged 40-74 years undergoing screening mammography, with or without supplemental screening with digital breast tomosynthesis or breast MRI, at selected BCSC facilities
- Women within 12 months of a digital screening mammogram with known breast density and no known breast cancer diagnosis
- For MRI subgroup, we will include women with a screening MRI within the prior 24 months
- Within strata defined by BCSC registry, breast density subgroup (dense vs. not dense), and race/ethnicity, women with supplemental screening with digital breast tomosynthesis or breast MRI will be matched to women without supplemental screening
- Aim 1 Focus Groups
- Inclusion criteria:
- Women age 40-74 years undergoing screening mammography, with or without supplemental screening (defined as digital breast tomosynthesis or breast MRI)
- Women within 12 months post-most recent screening examination with known dense breasts from most recent screening mammogram and no known breast cancer diagnosis
- Women who are able to speak English and can travel to a nearby location for a discussion
- Subaim 1
- Inclusion criteria:
- Radiologists interpreting digital mammography and/or tomosynthesis for at least one year from 2010-2017 at a facility that participates in the BCSC
- Digital mammography exams and digital breast tomosynthesis performed for screening and evaluated by a radiologist meeting inclusion criteria from 2010-2017
- Exclusion criteria:
- Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation
- Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
- Exams without complete cancer capture during one year following the screening mammogram
- Aim 2 Clinical Outcomes
- Inclusion criteria:
- Women at least 18 years of age with a first breast cancer diagnosis (DCIS or invasive) from 2005-2017 for whom there was a mammogram performed within the year prior to breast cancer diagnosis at one of the participating BCSC registry facilities
Where it is running
- 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
Full record on ClinicalTrials.gov
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