Study of Urine Samples From Women With Newly Diagnosed Breast Cancer Enrolled on Clinical Trial UNMC-08105
NCT ID: NCT00959244
Last Updated: 2023-09-01
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
100 participants
OBSERVATIONAL
2009-02-02
2009-09-25
Brief Summary
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PURPOSE: This research study is looking at urine samples from women with newly diagnosed breast cancer.
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Detailed Description
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* To learn the effects of selected agents (tamoxifen and aromatase inhibitors) on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.
OUTLINE: Previously collected urine samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultra-performance liquid chromatography with tandem mass spectrometric detection.
Patient information (e.g., race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption) is collected through medical record review.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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high performance liquid chromatography
Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
laboratory biomarker analysis
The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
mass spectrometry
Analyses of urine will be conducted by ultraperformance liquid chromatography with detection by tandem mass spectrometry.
medical chart review
Information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease, body mass index, age at menarche, menopausal status (pre- or peri- menopausal or postmenopausal), age at menopause if applicable, chemotherapy regimen (if applicable), radiation therapy (if applicable), smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy and disease type.
Eligibility Criteria
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Inclusion Criteria
* Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06), the Breast Cancer Collaborative Registry (BCCR), which included treatment with tamoxifen or an aromatase inhibitor
o Urine specimens were collected at baseline, 6 months, and then annually
* Estrogen receptor or progesterone receptor positive
* ECOG performance status 0-2
Exclusion Criteria
* No concurrent use of estrogen(s)
19 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Ercole Cavalieri, DSc
Role: PRINCIPAL_INVESTIGATOR
Eppley Cancer Center, University of Nebraska Medical Center
Locations
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Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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0502-08-EP
Identifier Type: -
Identifier Source: org_study_id
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