Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,201
- 试验地点
- 8
- 主要终点
- Within-individual mammographic density (MD) longitudinal change and breast cancer risk
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
时间窗: cancer cases diagnosed within the last 3 years (2004-2006).
Patterns of within-individual longitudinal change in MD
时间窗: cancer cases diagnosed within the last 3 years (2004-2006)
Predictors of across-individual differences in MD change
时间窗: cancer cases diagnosed within the last 3 years (2004-2006)
次要结局
未报告次要终点