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

• Conditions: Breast Cancer; Healthy, no Evidence of Disease
• Interventions: Procedure: Random fine need aspiration (rFNA); Other: Mammogram

• Registration Number: NCT00896636
• Lead Sponsor: Northwestern University

Brief 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.

Study Timeline

• Study Start: 2009-02-20
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2013-01-18
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-08-31
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 385

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follicular	Random fine need aspiration (rFNA)	Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.
Luteal	Random fine need aspiration (rFNA)	Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.
Luteal	Mammogram	Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.
Follicular	Mammogram	Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.
Menopause	Random fine need aspiration (rFNA)	Women who have entered menopause.
Menopause	Mammogram	Women who have entered menopause.

Primary Outcome Measures

Name	Time	Method
Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate	One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.
Differences in DNA methylation profiles between women in different menstrual stages	One time rFNA procedure to collect samples

Trial Locations

Locations (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States