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

Breast Cancer Clinical Trial

Official title:

Metabolic Genotypes and Oncogenic Damage in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766454
• Other study ID #: CDR0000573065
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: July 27, 2017
• Start date: November 1998
• Est. completion date: January 2010

Study information

• Verified date: October 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1104
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• DNA analysis

• mutation analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

• questionnaire administration

Procedure:
• evaluation of cancer risk factors

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Day 1