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Registry of Mastectomy for Breast Cancer Risk Reduction

NCT00555503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 261

Last updated 2016-12-02

No results posted yet for this study

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

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Scott L. Spear, M.D. · Georgetown University Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555503 on ClinicalTrials.gov