NCT02980848

Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study

Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,341,172 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Screening digital mammography	Screening with digital mammography alone
OTHER	Screening digital breast tomosynthesis	Screening with digital mammography plus digital breast tomosynthesis
OTHER	Screening breast magnetic resonance imaging	Screening with digital mammography plus breast magnetic resonance imaging
OTHER	Diagnostic mammography	Pre-operative diagnostic work-up with mammography alone
OTHER	Pre-operative breast magnetic resonance imaging	Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2016-12-02
• Last updated: 2021-11-17

Locations

7 sites across 1 country: United States