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Studying Urine and Blood Samples in Women With Newly Diagnosed Breast Cancer

Metabolic Genotypes and Oncogenic Damage in Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00766454
Enrollment
1104
Registered
2008-10-06
Start date
1998-11-30
Completion date
2010-01-31
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer

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.

Interventions

GENETICDNA analysis
GENETICmutation analysis
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis
OTHERmedical chart review
OTHERquestionnaire administration
PROCEDUREevaluation of cancer risk factors

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 developmentDay 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026