Clinical trialObservationalUnknown
Women At Risk: The High Risk Breast Cancer Program
- Outcome
- Outcome unknown
- Phase
- Observational
- Status
- Unknown
- Study type
- Observational
- Start
- January 1991
- Enrollment
- 2,000 participants
- Sites
- 2
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 18 December 2009
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 2000 participants (estimated).
Papers 1
- Registry-listed results paperBreast cancer risk factors in younger and older women. DOI 10.1245/s10434-008-0176-8↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.