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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00255060
Enrollment
100
Registered
2005-11-17
Start date
2001-11-30
Completion date
2007-06-30
Last updated
2010-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
United States Department of Defense
CollaboratorFED
Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026