Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Registry of Mastectomy for Breast Cancer Risk Reduction

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Scott L. Spear, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT00555503
First received: November 7, 2007
Last updated: February 14, 2013
Last verified: February 2013

November 7, 2007
February 14, 2013
November 2007
September 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 ]
Not Provided
Not Provided
 
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.

Not Provided
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.
 
Enrolling by invitation
500
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients at an elevated risk for breast cancer.

Exclusion Criteria:

  • None.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555503
2007-383
No
Scott L. Spear, M.D., Georgetown University
Georgetown University
Not Provided
Principal Investigator: Scott L. Spear, M.D. Georgetown University Hospital
Georgetown University
February 2013

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