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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 120
Updated:4/21/2016
Start Date:November 1998

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Metabolic Genotypes and Oncogenic Damage in Breast Cancer

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.

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.

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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mi
from
Winston-Salem, NC
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