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Registry of Mastectomy for Breast Cancer Risk Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scott L. Spear, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT00555503
First received: November 7, 2007
Last updated: December 1, 2016
Last verified: December 2016

November 7, 2007
December 1, 2016
November 2007
December 2013   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00555503 on ClinicalTrials.gov Archive Site
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 ]
Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following. [ Time Frame: 10 years ]
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Registry of Mastectomy for Breast Cancer Risk Reduction
Registry of Mastectomy for Breast Cancer Risk Reduction
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Patient operative specimens, blood samples, and saliva samples.
Non-Probability Sample
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.
  • Quality of Life
  • Mastectomy
  • Breast Neoplasms
  • Genetic Predisposition to Disease
  • Adjustment Disorder
Not Provided
1
Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients at an elevated risk for breast cancer.

Exclusion Criteria:

Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555503
2007-383
No
Not Provided
Not Provided
Scott L. Spear, M.D., Georgetown University
Georgetown University
Not Provided
Principal Investigator: Scott L. Spear, M.D. Georgetown University Hospital
Georgetown University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP