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


N/A
25 Years
65 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

James M Ford

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRSNSTU0002

NCT ID:

NCT00255060

Start Date:

November 2001

Completion Date:

June 2007

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317