Trial record 1 of 1 for:    NCT00555503
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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
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Mastectomy for Breast Cancer Risk Reduction

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Patient operative specimens, blood samples, and saliva samples.


Estimated Enrollment: 500
Study Start Date: November 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Patients at an elevated risk for breast cancer.

Exclusion Criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555503

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Scott L. Spear, M.D. Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Scott L. Spear, M.D., Chief Plastic Surgery, Georgetown University
ClinicalTrials.gov Identifier: NCT00555503     History of Changes
Other Study ID Numbers: 2007-383
Study First Received: November 7, 2007
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
prospective study
registry
quality of life
mastectomy
reconstructive surgical procedures
BrCa1
BrCa2
breast cancer prevention

Additional relevant MeSH terms:
Adjustment Disorders
Breast Neoplasms
Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Mental Disorders
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014