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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Luteal
Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.
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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).
Standard mammography of both breasts to obtain images for breast density measurement.
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Follicular
Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.
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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).
Standard mammography of both breasts to obtain images for breast density measurement.
|
|
Menopause
Women who have entered menopause.
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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).
Standard mammography of both breasts to obtain images for breast density measurement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Differences in DNA methylation profiles between women in different menstrual stages
Time Frame: One time rFNA procedure to collect samples.
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One time rFNA procedure to collect samples.
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Differences in DNA methylation profiles between women in different menstrual stages
Time Frame: One time rFNA procedure to collect samples
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One time rFNA procedure to collect samples
|
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Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate
Time Frame: One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.
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One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU 08B2
- P30CA060553 (U.S. NIH Grant/Contract)
- NU-08B2
- NU-IRB-STU00003136
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