Women At Risk: The High Risk Breast Cancer Program
- Conditions
- Breast Cancer
- Registration Number
- NCT01034891
- Lead Sponsor
- New York Presbyterian Hospital
- Brief Summary
The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.
- Detailed Description
This is a longitudinal cohort study that collects data of eligible women at risk for developing breast cancer. Patient information will be entered into a secured computerized database that is used for research on the prevention, early detection and treatment of breast cancer.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 2000
Inclusion Criteria
- one or more first-degree relatives (mother, daughter, or sister) with pre-menopausal breast cancer
- two or more first-degree relatives with post-menopausal breast cancer
- tested positive for a BRCA1 or BRCA2 mutation
- a history of biopsy-proven atypical ductal hyperplasia or atypical lobular hyperplasia
- a history of biopsy-proven lobular neoplasia (lobular carcinoma in situ)
Exclusion Criteria
- DCIS (ductal carcinoma in situ)
- previous diagnosis of breast cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Women At Risk, Weill Cornell
🇺🇸New York, New York, United States
Women At Risk, Columbia University Medical Center
🇺🇸New York, New York, United States