Breast Cancer Clinical Trial
Official title:
Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
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.
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.
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