Registry of Mastectomy for Breast Cancer Risk Reduction
N/A
18 Years
70 Years
18 Years
70 Years
Open (Enrolling by invite only)
Both
Quality of Life, Mastectomy, Breast Neoplasms, Genetic Predisposition to Disease, Adjustment Disorder
Both
Quality of Life, Mastectomy, Breast Neoplasms, Genetic Predisposition to Disease, Adjustment Disorder
Trial Information
Registry of Mastectomy for Breast Cancer Risk Reduction
Inclusion Criteria:
- Patients at an elevated risk for breast cancer.
Exclusion Criteria:
- None.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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.
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Scott L. Spear, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Georgetown University Hospital
Authority:
United States: Institutional Review Board
Study ID:
2007-383
NCT ID:
NCT00555503
Start Date:
November 2007
Completion Date:
September 2013
Related Keywords:
- Quality of Life
- Mastectomy
- Breast Neoplasms
- Genetic Predisposition to Disease
- Adjustment Disorder
- prospective study
- registry
- quality of life
- mastectomy
- reconstructive surgical procedures
- BrCa1
- BrCa2
- breast cancer prevention
- Adjustment Disorders
- Breast Neoplasms
- Neoplasms
- Disease Susceptibility
Name | Location |
|---|---|
| Georgetown University Hospital | Washington, District of Columbia 20007 |
