Status:
UNKNOWN
Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Healthy, no Evidence of Disease
Eligibility:
FEMALE
35-60 years
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 20 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00896636
Start Date
February 20 2009
End Date
January 1 2022
Last Update
August 31 2020
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013