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Metabolic Genotypes and Oncogenic Damage in Breast Cancer


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Metabolic Genotypes and Oncogenic Damage in Breast Cancer


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome 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

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Steven A. Akman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000573065

NCT ID:

NCT00766454

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096