Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Metabolic Genotypes and Oncogenic Damage in Breast Cancer |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1100 |
| Study Start Date: | November 1998 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Those with newly diagnosed breast cancer who are planning to undergo a diagnostic biopsy or surgery.
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Study Chair: | Steven A. Akman, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00766454 History of Changes |
| Other Study ID Numbers: | CDR0000573065, P30CA012197, CCCWFU-98298, CCCWFU-BG98-278 |
| Study First Received: | October 3, 2008 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013