Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, breast cancer in situ
Brief 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.
Interventions
OTHERphysiologic testing
Urine samples will be assessed for levels of bisphenol-A
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.
PROCEDUREbreast 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.
PROCEDUREradiomammography
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.
PROCEDUREstudy 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
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system * Have at least 3 screening mammograms since 1994 * for cases, diagnosis with breast cancer between 2004-2006
Exclusion criteria
* having had irregular screening (less than 3 mammorgrams since 1994) * Having breast implants * Known carriers of BRCA1/BRCA2 genes * Unable to give written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within-individual mammographic density (MD) longitudinal change and breast cancer risk | cancer cases diagnosed within the last 3 years (2004-2006). |
| Patterns of within-individual longitudinal change in MD | cancer cases diagnosed within the last 3 years (2004-2006) |
| Predictors of across-individual differences in MD change | cancer cases diagnosed within the last 3 years (2004-2006) |
Countries
United States
Outcome results
None listed