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临床试验/NCT00766454
NCT00766454已完成不适用

Metabolic Genotypes and Oncogenic Damage in Breast Cancer

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 1,104 人开始时间: 1998年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,104
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 120 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Psychiatric history that would preclude giving informed consent

结局指标

主要结局

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

时间窗: Day 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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