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

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.

Conditions

• Breast Cancer

Interventions

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

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Dartmouth College

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• University of Vermont

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Harvard Pilgrim Health Care

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University of California, Davis

  lead OTHER

Principal Investigators

• Diana L Miglioretti, PhD · University of California, Davis

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2022-02-28

Completion

2022-02-28

Countries

• United States

Study Locations