Status:
RECRUITING
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
Lead Sponsor:
Carol Fabian, MD
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-65 years
Brief Summary
The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarker...
Detailed Description
1. To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol and IGF-1...
Eligibility Criteria
Inclusion
- women with at least 2 times the normal risk of developing breast cancer
- between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
- greater than six months from ingestion of antihormonal therapy
- greater than 1 year from pregnancy, lactation, or chemotherapy
- willing to have a mammogram within six months prior to RPFNA
- willing to discontinue NSAIDS or herbal supplements
- willing to have blood drawn
Exclusion
- no metastatic malignancy of any kind
- no breast implants or tram flap reconstructions
- no radiation to both breasts
- no women who have a current mammogram or clinical breast exam suspicious for cancer
Key Trial Info
Start Date :
August 1 1989
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00291096
Start Date
August 1 1989
End Date
December 1 2027
Last Update
October 29 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160