Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk
35 Years
60 Years
Female
Breast Cancer, Healthy, no Evidence of Disease
Trial Information
Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Differences in DNA methylation profiles between women in different menstrual stages
Outcome Time Frame:
One time rFNA procedure to collect samples.
Safety Issue:
No
Principal Investigator
Seema A. Khan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
NU 08B2
NCT ID:
NCT00896636
Start Date:
May 2008
Completion Date:
April 2015
Related Keywords:
- Breast Cancer
- Healthy, no Evidence of Disease
- breast cancer
- healthy, no evidence of disease
- Breast Neoplasms
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
