NCT00445445

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

Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,201 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

OBJECTIVES: * Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk. * Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences. * Determine whether the developmental profile of MD differs systematically between these patients and healthy participants. OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity. * 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. PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-01-10
• Primary completion: 2014-07-21
• Completion: 2014-07-21
• First posted: 2007-03-09
• Last updated: 2020-02-11

Locations

8 sites across 1 country: United States