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
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Carcinoma in Situ
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): high performance liquid chromatography; laboratory biomarker analysis; mass spectrometry; medical chart review; evaluation of cancer risk factors
Intervention type(s): Other; Other; Other; Other; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The target population is adult women, ages 19 to 80 years of age. In 2003, there were
        approximately 2000 new and 3000 established patient visits in the Breast Diagnostic Clinic
        (BDC) and Breast Cancer Clinic (BCC) Our new patients include those seen in the BDC with
        new breast concerns and those at seeking counseling regarding a family history or at high
        risk for developing breast cancer, as well as those women seen in the BCC with a new
        diagnosis of invasive or non-invasive breast cancer.
      
Keywords: breast cancer; ductal breast carcinoma in situ; breast cancer in situ; stage IA breast cancer; stage IB breast cancer; stage II breast cancer