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Spots Global Cancer Trial Database for Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Diana L Miglioretti, PhD

Affiliation: University of California, Davis

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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