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.

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Key information

Conditions

Quality of Life Adjustment Disorder Adjustment Disorders Breast Diseases Breast Neoplasms Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Mastectomy Mental Disorders Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients at an elevated risk for breast cancer.

Exclusion criteria

None.

Treatment and study plan

Primary outcomes

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 outcomes

Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following.

Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2014
First posted: Nov 8, 2007
Registry last updated: Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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