Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Healthy, no Evidence of Disease |
Procedure: Random fine need aspiration (rFNA) Other: Mammogram |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk |
- Differences in DNA methylation profiles between women in different menstrual stages [ Time Frame: One time rFNA procedure to collect samples. ] [ Designated as safety issue: No ]
- Differences in DNA methylation profiles between women in different menstrual stages [ Time Frame: One time rFNA procedure to collect samples ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Breast tissue random fine needle aspiration (rFNA) samples will be collected and levels of methylation and hormones will be measured in each.
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Luteal
Pre-menopausal women who undergo rFNA procedure during the luteal phase of their menstrual cycle.
|
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.
|
|
Follicular
Pre-menopausal women who undergo rFNA procedure during the follicular phase of their menstrual cycle.
|
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.
|
|
Menopause
Women who have entered menopause.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women coming in for screening mammography, for diagnostic imaging, for evaluation of benign breast problems, and for breast cancer risk evaluation who have no history of breast cancer.
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
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Principal Investigator: | Seema A. Khan, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00896636 History of Changes |
| Other Study ID Numbers: | NU 08B2, P30CA060553, NU-08B2, NU-IRB-STU00003136 |
| Study First Received: | May 9, 2009 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
breast cancer healthy, no evidence of disease |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013