Scripps Polster Breast Care Center Investigational GeneBank (PINK)
Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. The investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. If the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. In contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. Using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer.
By developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
California
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La Jolla、California、アメリカ、92037
- Scripps Polster Breast Care Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 30 years or older
- Be reliable, cooperative and willing to comply with all protocol-specified procedures
- Able to understand and grant informed consent
- Be undergoing screening or diagnostic breast imaging
- Have at least 5 years of breast imaging data available
Exclusion Criteria:
- Have a significant chronic medical condition which, in the Investigator's opinion, would interfere with the subject's participation in the study
- Have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study
- Have taken any CNS sedation or depressants in past 12 hours
研究計画
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 |
|---|---|
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No treatment
Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center.
|
Subjects are required only to provide a blood or saliva sample, relevant personal and family history (if available), and 5 years of historic breast imaging reports.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Genotyping
時間枠：End of study
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Genotype a panel of single nucleotide polymorphisms (SNPs) previously shown to be highly associated with increased risk to breast cancer in a cohort of women with either at least 5 years of historical breast imaging data available or 30-45 year old breast cancer patients with at least one year imaging data
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End of study
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協力者と研究者
捜査官
- 主任研究者：Eric J Topol, MD、Scripps Translational Science Institute and Genomic Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LAJ 08-8001
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。