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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Neoplasms; Genetic Predisposition to Disease; Adjustment Disorder; Mastectomy

• Study Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Patients at an elevated risk for breast cancer.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following.	10 years

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Scott L. Spear, M.D., Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 7, 2007
• First Submitted That Met QC Criteria: November 7, 2007
• First Posted (Estimate): November 8, 2007

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; registry; mastectomy; prospective study; breast cancer prevention; reconstructive surgical procedures; BrCa1; BrCa2
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Trauma and Stressor Related Disorders; Breast Neoplasms; Disease Susceptibility; Genetic Predisposition to Disease; Adjustment Disorders
• Other Study ID Numbers: 2007-383