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
NCT ID: NCT00897208
Last Updated: 2018-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
316 participants
OBSERVATIONAL
2005-05-20
2015-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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high performance liquid chromatography
laboratory biomarker analysis
mass spectrometry
medical chart review
evaluation of cancer risk factors
Eligibility Criteria
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Inclusion Criteria
* 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
19 Years
80 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Sandhya Pruthi, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Countries
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Other Identifiers
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19-2005
Identifier Type: OTHER
Identifier Source: secondary_id
06-008665
Identifier Type: OTHER
Identifier Source: secondary_id
19-2005
Identifier Type: -
Identifier Source: org_study_id
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