Registry of Mastectomy for Breast Cancer Risk Reduction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00555503

Enrollment

261

Registered

2007-11-08

Start date

2007-11-30

Completion date

2014-01-31

Last updated

2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients at an elevated risk for breast cancer.

Exclusion criteria

* None.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results