Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer
NCT ID: NCT00766454
Last Updated: 2017-08-01
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
1104 participants
OBSERVATIONAL
1998-11-30
2010-01-31
Brief Summary
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PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer.
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Detailed Description
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* To determine the association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) in women with newly diagnosed breast cancer that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development.
OUTLINE: Urine and blood samples are collected for DNA, mutation, and polymorphism analysis. The biological samples may be stored and used for future research.
Patients complete a Baseline Questionnaire to collect basic risk/exposure information, including demographic factors (e.g., age, weight, height, and body mass index), menstrual/reproductive history, medical history, medication use, smoking history, alcohol consumption, exposure to chest x-ray, and family history of breast cancer in first-degree relatives. Patients also complete a Second Hand Smoke Questionnaire to collect information on cigarette smoking history and second hand smoke exposure and a Food Frequency Questionnaire to collect information on the frequency of use of specific fruits and vegetables (e.g., cruciferous vegetables) and to estimate usual dietary intake of 33 nutrients during the past year (e.g., total fat, saturated fat, oleic fat, linoleic fat, carbohydrates, protein, vitamins \[e.g., A, B1, B2, niacin, B6, folate, C, and E\], minerals \[e.g., calcium, magnesium, iron, and zinc\], electrolytes \[e.g., sodium and potassium\], and dietary fiber). Patients' medical charts are also reviewed to collect information on age, gender, ethnic background, medical history, and medical care.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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DNA analysis
mutation analysis
polymorphism analysis
laboratory biomarker analysis
medical chart review
questionnaire administration
evaluation of cancer risk factors
Eligibility Criteria
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Inclusion Criteria
* Planning to undergo a diagnostic biopsy or surgery
* Must have tumor tissue available
* Hormone receptor status not specified
* More than 6 months since prior chemotherapy or radiotherapy
* Pre- or post-menopausal
Exclusion Criteria
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Steven A. Akman, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU-98298
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-BG98-278
Identifier Type: -
Identifier Source: secondary_id
CDR0000573065
Identifier Type: -
Identifier Source: org_study_id
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