Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00766454|
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : August 1, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: DNA analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review Other: questionnaire administration Procedure: evaluation of cancer risk factors|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1104 participants|
|Official Title:||Metabolic Genotypes and Oncogenic Damage in Breast Cancer|
|Study Start Date :||November 1998|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- Association between the genotype for 4 metabolic enzymes (e.g., CYP1A1, GSTM, GSTT, and GSTP) that play key roles in the metabolism of environmental human carcinogens and the risk of breast cancer development [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766454
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Steven A. Akman, MD||Wake Forest University Health Sciences|