Registry of Mastectomy for Breast Cancer Risk Reduction

NCT00555503 | Completed

• 1 other identifier: 2007-383
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

prospective study; registry; quality of life; mastectomy; reconstructive surgical procedures; BrCa1; BrCa2; breast cancer prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  10 years

Study Arms (1)

1

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients at an elevated risk for breast cancer.

You may not qualify if:

• None.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Hospital

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patient operative specimens, blood samples, and saliva samples.

MeSH Terms

Conditions

Breast Neoplasms; Genetic Predisposition to Disease; Adjustment Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Scott L. Spear, M.D.

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Plastic Surgery

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 8, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 2, 2016

Record last verified: 2016-12

Locations

US (1)