An observational study in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 8 sites in United States. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Case Comprehensive Cancer Center · Observational
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:
OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.
PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2,201 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
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Breast cancer cases diagnosed after 1994 and equal number of frequency-matched (by age within 2 years and ethnicity) controls. Cases and eligible controls with at least 3 screening mammograms since 1994 will be recruited through the University Hospitals Breast Center, and primary care clinics within the University Hospitals Health System (UHHS). The restriction of 3 or more screening mammograms will allow us to adequately model the longitudinal change patterns.
Exclusion criteria:
Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Other: physiologic testing · Other: screening questionnaire administration · Procedure: breast imaging study · Procedure: radiomammography · Procedure: study of high risk factors
Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
Other: physiologic testing · Other: screening questionnaire administration · Procedure: breast imaging study · Procedure: radiomammography · Procedure: study of high risk factors
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.
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.
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.
* 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.
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
Time frame: cancer cases diagnosed within the last 3 years (2004-2006).
Patterns of within-individual longitudinal change in MD
Time frame: cancer cases diagnosed within the last 3 years (2004-2006)
Predictors of across-individual differences in MD change
Time frame: cancer cases diagnosed within the last 3 years (2004-2006)
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center