Registry of Mastectomy for Breast Cancer Risk Reduction

Quality of Life Clinical Trial

Official title:

Registry of Mastectomy for Breast Cancer Risk Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555503
• Other study ID #: 2007-383
• Status: Completed
• Phase: N/A
• First received: November 7, 2007
• Last updated: December 1, 2016
• Start date: November 2007
• Est. completion date: January 2014

Study information

• Verified date: December 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients at an elevated risk for breast cancer.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adjustment Disorder
• Adjustment Disorders
• Breast Neoplasms
• Disease Susceptibility
• Genetic Predisposition to Disease
• Mastectomy
• Quality of Life

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following.		10 years	Yes