Registry of Mastectomy for Breast Cancer Risk Reduction
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Purpose
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.
| Condition |
|---|
|
Quality of Life Mastectomy Breast Neoplasms Genetic Predisposition to Disease Adjustment Disorder |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 500 |
| 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) |
| Groups/Cohorts |
|---|
|
1
Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients are enrolled from the plastic surgery, breast surgery, or oncology clinics at Georgetown University Hospital who are at elevated risk for breast cancer. Please note that the Registry can only enroll Georgetown University Hospital patients.
Inclusion Criteria:
- Patients at an elevated risk for breast cancer.
Exclusion Criteria:
- None.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Scott L. Spear, M.D., Chief Plastic Surgery, Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00555503 History of Changes |
| Other Study ID Numbers: | 2007-383 |
| Study First Received: | November 7, 2007 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Georgetown University:
|
prospective study registry quality of life mastectomy |
reconstructive surgical procedures BrCa1 BrCa2 breast cancer prevention |
Additional relevant MeSH terms:
|
Adjustment Disorders Breast Neoplasms Neoplasms Disease Susceptibility Genetic Predisposition to Disease Mental Disorders |
Neoplasms by Site Breast Diseases Skin Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013