Registry of Mastectomy for Breast Cancer Risk Reduction

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Scott L. Spear, M.D., Georgetown University Identifier:
First received: November 7, 2007
Last updated: February 11, 2015
Last verified: February 2015
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
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

Resource links provided by NLM:

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00555503

United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: Scott L. Spear, M.D. Georgetown University Hospital
  More Information

Responsible Party: Scott L. Spear, M.D., Chief Plastic Surgery, Georgetown University Identifier: NCT00555503     History of Changes
Other Study ID Numbers: 2007-383 
Study First Received: November 7, 2007
Last Updated: February 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
prospective study
quality of life
reconstructive surgical procedures
breast cancer prevention

Additional relevant MeSH terms:
Adjustment Disorders
Breast Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Breast Diseases
Disease Attributes
Mental Disorders
Neoplasms by Site
Pathologic Processes
Skin Diseases
Trauma and Stressor Related Disorders processed this record on May 26, 2016