Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer
Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer.
PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II breast cancer and in women at risk of developing breast cancer.
調査の概要
詳細な説明
OBJECTIVES:
- To determine the levels of catechol estrogens (CE), CE metabolites, CE-DNA adducts, and CE conjugates in nipple aspirate fluid samples obtained from women with newly diagnosed ductal carcinoma in situ or stage I or II breast cancer and from women at high risk of developing breast cancer.
OUTLINE: Patients with newly diagnosed breast cancer or at high risk of developing breast cancer undergo nipple aspiration. The nipple aspirate fluid is obtained from the unaffected breast and is analyzed for 31 estrogen metabolites, conjugates, and depurinating DNA adducts by high-performance liquid chromatography (LC) with electrochemical and mass spectrometric detectors. All patients undergo urine and serum sample collection. The urine samples are analyzed by ultraperformance LC monitored by tandem mass spectrometry for estrogen metabolites, conjugates, and depurinating DNA adducts.
Patients' charts are reviewed to obtain information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, and HER2/neu status (for patients with newly diagnosed breast cancer), menopausal status, reproductive history, history of breast disease, medication use, smoking history, and history of alcohol consumption.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer 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
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Newly diagnosed (within 30 calendar days of diagnosis) stage I or II breast cancer
- Node-negative or node-positive disease
- Newly diagnosed ductal carcinoma in situ (stage 0) of the breast
At high risk of developing breast cancer, as indicated by at least 1 of the following criteria:
- Gail model 5-year risk score ≥ 1.66%
- Gail model lifetime-risk estimate ≥ 20%
- Known deleterious BRCA 1 or 2 gene mutation carrier
- History of lobular carcinoma in situ or atypical ductal or lobular hyperplasia
At low or average risk of developing breast cancer (control group)
- Gail model 5-year risk score < 1.66% or lifetime risk < 20%
- No advanced breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Pre- or post-menopausal
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for breast cancer or any other cancer
- More than 3 months since prior and no concurrent estrogen or other hormones
- More than 3 months since prior oral contraceptives
- No concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)
- No concurrent aromatase inhibitors
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
- 観測モデル:コホート
- 時間の展望:見込みのある
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 |
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Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Sandhya Pruthi, MD、Mayo Clinic
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
- 19-2005 (Mayo Clinic Cancer Center)
- 06-008665 (その他の識別子:Mayo Clinic IRB)
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