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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00255060
Collaborator
National Institutes of Health (NIH) (NIH), United States Department of Defense (U.S. Fed)
100
Enrollment
1
Location
67
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
    Study Start Date :
    Nov 1, 2001
    Actual Primary Completion Date :
    Jul 1, 2006
    Actual Study Completion Date :
    Jun 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      25 Years to 65 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No

      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Stanford University School of Medicine Stanford California United States 94305

      Sponsors and Collaborators

      • Stanford University
      • National Institutes of Health (NIH)
      • United States Department of Defense

      Investigators

      • Principal Investigator: James M Ford, Stanford University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00255060
      Other Study ID Numbers:
      • BRSNSTU0002
      • 77716
      • BRSNSTU0002
      First Posted:
      Nov 17, 2005
      Last Update Posted:
      Jul 20, 2010
      Last Verified:
      Jul 1, 2010
      Additional relevant MeSH terms:
      Breast Neoplasms

      Study Results

      No Results Posted as of Jul 20, 2010