Breast Cancer Clinical Trial
Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration
Summary
RATIONALE: Studying samples of blood and breast tissue from healthy women in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to breast cancer risk.
PURPOSE: This research study is looking at breast tissue in women not previously diagnosed with breast cancer who are undergoing fine-needle aspiration.
Full Description
OBJECTIVES:
Primary
To determine if breast tissue DNA methylation profile and hormone concentration change across follicular and luteal phase, or across menopause, in random fine needle aspiration samples of women with no prior diagnosis or treatment for breast cancer.
To determine if DNA methylation profile and breast hormone levels correlate with mammographic density, cytomorphology, or Gail risk estimates.
To develop a high throughput commercial assay for DNA methylation profiling for assessing breast cancer risk.
To develop a highly sensitive, specific, and novel nanoassay for estradiol and progesterone.
OUTLINE: This is a multicenter study.
Premenopausal women are stratified by menstrual cycle phase (mid-follicular [day 5-10] vs mid-luteal [day 20-25]), based on an adjusted 28-day cycle.
Patients undergo breast density measurement by digital mammography. Blood samples are obtained and analyzed for estradiol, progesterone, and follicle-stimulating hormone measurements, to define menstrual/menopausal status, and for DNA extraction. Patients also undergo random fine needle aspiration. Biopsy material from aspiration is analyzed for cytomorphology, steroid radioimmunoassay (RIA), steroid nanoassay, and DNA methylation studies (via polymerase chain reaction). The aspiration samples are also analyzed for estradiol and progesterone levels using high-pressure liquid chromatography and RIA.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Women meeting one of the following requirements:
Regularly cycling premenopausal women under 45 years of age
Perimenopausal women 45-55 years of age who have had ≥ two periods in the past 6 months
Postmenopausal women under 60 years of age (no menstrual period for 12 months and follicle-stimulating hormone (FSH) levels > 25 IU/dL)
No history of breast cancer diagnosis or prior treatment for breast cancer
Negative breast evaluation within the past 3 months
PATIENT CHARACTERISTICS:
See Disease Characteristics
PRIOR CONCURRENT THERAPY:
No concurrent oral contraceptives
At least 2 weeks since prior aspirin, non-steroidal anti-inflammatory drugs, and vitamin E
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There is 1 Location for this study
Chicago Illinois, 60611, United States
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