Registry of Mastectomy for Breast Cancer Risk Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555503
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
Scott L. Spear, M.D., Georgetown University

Brief Summary:
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 or disease
Quality of Life Mastectomy Breast Neoplasms Genetic Predisposition to Disease Adjustment Disorder

Study Type : Observational
Actual Enrollment : 261 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Mastectomy for Breast Cancer Risk Reduction
Study Start Date : November 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following. [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Patient operative specimens, blood samples, and saliva samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Scott L. Spear, M.D., Chief Plastic Surgery, Georgetown University Identifier: NCT00555503     History of Changes
Other Study ID Numbers: 2007-383
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016

Keywords provided by Scott L. Spear, M.D., Georgetown University:
prospective study
quality of life
reconstructive surgical procedures
breast cancer prevention

Additional relevant MeSH terms:
Breast Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Adjustment Disorders
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders