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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-20

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Healthy, no Evidence of Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Luteal

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

Random fine need aspiration (rFNA)

Intervention Type PROCEDURE

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).

Mammogram

Intervention Type OTHER

Standard mammography of both breasts to obtain images for breast density measurement.

Follicular

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

Random fine need aspiration (rFNA)

Intervention Type PROCEDURE

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).

Mammogram

Intervention Type OTHER

Standard mammography of both breasts to obtain images for breast density measurement.

Menopause

Women who have entered menopause.

Random fine need aspiration (rFNA)

Intervention Type PROCEDURE

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).

Mammogram

Intervention Type OTHER

Standard mammography of both breasts to obtain images for breast density measurement.

Interventions

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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).

Intervention Type PROCEDURE

Mammogram

Standard mammography of both breasts to obtain images for breast density measurement.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes