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

Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00255060
First received: November 15, 2005
Last updated: July 16, 2010
Last verified: July 2010

November 15, 2005
July 16, 2010
November 2001
July 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00255060 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.

The following are our specific goals in this endeavor;

  1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
  2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
  3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a >10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women with high risk of breast cancer

Breast Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2007
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:Subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the Claus Model).

May have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.

Female
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255060
BRSNSTU0002, 77716, BRSNSTU0002
Not Provided
James M Ford, Stanford University School of Medicine
Stanford University
  • National Institutes of Health (NIH)
  • Department of Defense
Principal Investigator: James M Ford Stanford University
Stanford University
July 2010

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