Registry of Mastectomy for Breast Cancer Risk Reduction
This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.
Quality of Life
Genetic Predisposition to Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Registry of Mastectomy for Breast Cancer Risk Reduction|
- The primary study endpoint is the quality of life of the individual patient at the end of one year. Quality of life is measured using standardized self-report instruments administered preoperatively and in annual follow-up. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Patient operative specimens, blood samples, and saliva samples.
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555503
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Scott L. Spear, M.D.||Georgetown University Hospital|