Registry of Mastectomy for Breast Cancer Risk Reduction - Full Text View

Sponsor:	Georgetown University
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00555503

Purpose

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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Registry of Mastectomy for Breast Cancer Risk Reduction

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy Surgery

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Patient operative specimens, blood samples, and saliva samples.

Estimated Enrollment:	500
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2012

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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.

Criteria

Inclusion Criteria:

Patients at an elevated risk for breast cancer.

Exclusion Criteria:

None.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555503

Locations

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

Sponsors and Collaborators

Georgetown University

Investigators

Principal Investigator:

Scott L. Spear, M.D.

Georgetown University Hospital

More Information

No publications provided

Responsible Party:	Georgetown University Hospital Department of Plastic Surgery ( Scott Spear, MD )
Study ID Numbers:	2007-383
Study First Received:	November 7, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00555503 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

prospective study
registry
quality of life
mastectomy

reconstructive surgical procedures
BrCa1
BrCa2
breast cancer prevention

Additional relevant MeSH terms:

Adjustment Disorders
Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases

Disease Susceptibility
Mental Disorders
Breast Neoplasms
Genetic Predisposition to Disease
Breast Diseases

ClinicalTrials.gov processed this record on November 20, 2009