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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
観察的
入学 (実際)
2201
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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Mayfield Heights、Ohio、アメリカ、44124
- UH-Monarch
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Mentor、Ohio、アメリカ、44060
- UH-LUICC
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Middleburg Heights、Ohio、アメリカ、44130
- UH-Southwest
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Orange Village、Ohio、アメリカ、44122
- UH-Chagrin Highlands Orange Village Ohio 44122
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Sandusky、Ohio、アメリカ、44870
- UH-Firelands
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South Euclid、Ohio、アメリカ、44121
- UH-Green Road
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Westlake、Ohio、アメリカ、44145
- UH-Westlake
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
時間枠：cancer cases diagnosed within the last 3 years (2004-2006).
|
cancer cases diagnosed within the last 3 years (2004-2006).
|
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Patterns of within-individual longitudinal change in MD
時間枠：cancer cases diagnosed within the last 3 years (2004-2006)
|
cancer cases diagnosed within the last 3 years (2004-2006)
|
|
Predictors of across-individual differences in MD change
時間枠：cancer cases diagnosed within the last 3 years (2004-2006)
|
cancer cases diagnosed within the last 3 years (2004-2006)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Cheryl Thompson, PhD、University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2007年1月10日
一次修了 (実際)
2014年7月21日
研究の完了 (実際)
2014年7月21日
試験登録日
最初に提出
2007年3月7日
QC基準を満たした最初の提出物
2007年3月7日
最初の投稿 (見積もり)
2007年3月9日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月11日
QC基準を満たした最後の更新が送信されました
2020年2月10日
最終確認日
2020年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CASE1105 (その他の識別子：Case Comprehensive Cancer Center)
- P30CA043703 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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