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Registry of Mastectomy for Breast Cancer Risk Reduction

NCT ID: NCT00555503

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

261 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients at an elevated risk for breast cancer.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Scott L. Spear, M.D.

Chief Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott L. Spear, M.D.

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Locations

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Georgetown University Hospital

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

Site Status

Countries

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United States

Other Identifiers

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2007-383

Identifier Type: -

Identifier Source: org_study_id