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Clinical Trials/NCT00766454
NCT00766454
Completed
Not Applicable

Metabolic Genotypes and Oncogenic Damage in Breast Cancer

Wake Forest University Health Sciences1 site in 1 country1,104 target enrollmentNovember 1998
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
1104
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1998
End Date
January 2010
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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