Clinical trial NCT00766454: Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer
Official title: Metabolic Genotypes and Oncogenic Damage in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-10-06
Enrollment: 1104
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with newly diagnosed breast cancer who are planning to undergo a diagnostic biopsy or surgery.

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: 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
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven A. Akman, MD
role: STUDY_CHAIR
References: