Breast Cancer Clinical Trial
Official title:
Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk
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.
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.
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