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

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ClinicalTrials.gov Identifier: NCT00255060
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : July 20, 2010
Sponsor:
Collaborators:
Information provided by:

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
Breast Cancer

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
Estimated 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 : November 2001
Primary Completion Date : July 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with high risk of breast cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255060


Locations
United States, California
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
More Information

Responsible Party: James M Ford, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00255060     History of Changes
Other Study ID Numbers: BRSNSTU0002
77716
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases