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Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk

35 Years
60 Years
Open (Enrolling)
Breast Cancer, Healthy, no Evidence of Disease

Thank you

Trial Information

Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk



- 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

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


- 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

- 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


- See Disease Characteristics


- No concurrent oral contraceptives

- At least 2 weeks since prior aspirin, non-steroidal anti-inflammatory drugs, and
vitamin E

Type of Study:


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:


Principal Investigator

Seema A. Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Institutional Review Board

Study ID:

NU 08B2



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



Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611