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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sandhya Pruthi, MD, Mayo Clinic
Datas de registro do estudo
Datas Principais do Estudo
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Conclusão do estudo (Real)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 19-2005 (Mayo Clinic Cancer Center)
- 06-008665 (Outro identificador: Mayo Clinic IRB)
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