Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration

Northwestern University

Status: Unknown

Conditions: Breast Cancer; Healthy, no Evidence of Disease

Treatments: Other: Mammogram; Procedure: Random fine need aspiration (rFNA)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00896636

NU-IRB-STU00003136

NU 08B2

P30CA060553 (U.S. NIH Grant/Contract)

NU-08B2

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

385 participants in 3 patient groups

Luteal

Description:

Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.

Treatment:

Other: Mammogram

Procedure: Random fine need aspiration (rFNA)

Follicular

Description:

Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.

Treatment:

Other: Mammogram

Procedure: Random fine need aspiration (rFNA)

Menopause

Description:

Women who have entered menopause.

Treatment:

Other: Mammogram

Procedure: Random fine need aspiration (rFNA)