Registry of Mastectomy for Breast Cancer Risk Reduction

Completed

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

• Registration Number: NCT00555503
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-07
• Study First Submitted QC: 2007-11-07
• Study First Posted: 2007-11-08
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• Patients at an elevated risk for breast cancer.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States