Breast Cancer Clinical Trial

Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer

Summary

RATIONALE: Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at urine and blood samples in women with newly diagnosed breast cancer.

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Full Description

OBJECTIVES:

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.

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Eligibility Criteria

Inclusion Criteria:

Newly diagnosed breast cancer
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:

-Psychiatric history that would preclude giving informed consent

Study is for people with:

Breast Cancer

Estimated Enrollment:

1104

Study ID:

NCT00766454

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1104

Study ID:

NCT00766454

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

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