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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00896636
• Other study ID #: NU 08B2
• Secondary ID: P30CA060553NU-08
• Status: Active, not recruiting
• Start date: February 20, 2009
• Est. completion date: January 2022

Study information

• Verified date: August 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 385
• Est. completion date: January 2022
• Est. primary completion date: January 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Healthy, no Evidence of Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in DNA methylation profiles between women in different menstrual stages		One time rFNA procedure to collect samples.
Primary	Differences in DNA methylation profiles between women in different menstrual stages		One time rFNA procedure to collect samples
Primary	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.