Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

Summary

RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.

PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Conditions

• Breast Cancer

Interventions

OTHER

physiologic testing

Urine samples will be assessed for levels of bisphenol-A

OTHER

screening questionnaire administration

Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.

PROCEDURE

breast imaging study

Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

PROCEDURE

radiomammography

Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

PROCEDURE

study of high risk factors

* Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk. * Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Cheryl Thompson, PhD · University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Eligibility

Min Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-01-10

Primary Completion

2014-07-21

Completion

2014-07-21

Countries

• United States

Study Locations