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Clinical Trials/NCT00255060
NCT00255060
Completed
Not Applicable

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

Stanford University1 site in 1 country100 target enrollmentNovember 2001
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Stanford University
Enrollment
100
Locations
1
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2001
End Date
June 2007
Last Updated
15 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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