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OpenTrials
Completed

NCT Number: NCT00255060

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

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

Completed

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Key information

Age range

25 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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;

  • To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Important dates

Study start
2001
Primary completion
2006
Study completion
2007
First posted
Nov 17, 2005
Registry last updated
Jul 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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