Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
2020年2月10日 更新者：Case Comprehensive Cancer Center
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
2201
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cleveland、Ohio、美国、44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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Mayfield Heights、Ohio、美国、44124
- UH-Monarch
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Mentor、Ohio、美国、44060
- UH-LUICC
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Middleburg Heights、Ohio、美国、44130
- UH-Southwest
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Orange Village、Ohio、美国、44122
- UH-Chagrin Highlands Orange Village Ohio 44122
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Sandusky、Ohio、美国、44870
- UH-Firelands
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South Euclid、Ohio、美国、44121
- UH-Green Road
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Westlake、Ohio、美国、44145
- UH-Westlake
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients
Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
|
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.
|
|
Healthy participants
Healthy participant who is receiving routine medical care (e.g., screening mammograms.
Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Within-individual mammographic density (MD) longitudinal change and breast cancer risk
大体时间：cancer cases diagnosed within the last 3 years (2004-2006).
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cancer cases diagnosed within the last 3 years (2004-2006).
|
|
Patterns of within-individual longitudinal change in MD
大体时间：cancer cases diagnosed within the last 3 years (2004-2006)
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cancer cases diagnosed within the last 3 years (2004-2006)
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Predictors of across-individual differences in MD change
大体时间：cancer cases diagnosed within the last 3 years (2004-2006)
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cancer cases diagnosed within the last 3 years (2004-2006)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Cheryl Thompson, PhD、University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年1月10日
初级完成 (实际的)
2014年7月21日
研究完成 (实际的)
2014年7月21日
研究注册日期
首次提交
2007年3月7日
首先提交符合 QC 标准的
2007年3月7日
首次发布 (估计)
2007年3月9日
研究记录更新
最后更新发布 (实际的)
2020年2月11日
上次提交的符合 QC 标准的更新
2020年2月10日
最后验证
2020年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.