NCT00896636

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 385 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
PROCEDURE	Random fine need aspiration (rFNA)	Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).
OTHER	Mammogram	Standard mammography of both breasts to obtain images for breast density measurement.

Timeline

• Start date: 2009-02-20
• Primary completion: 2013-01-18
• Completion: 2022-01-01
• First posted: 2009-05-12
• Last updated: 2020-08-31

Locations

1 site across 1 country: United States