Single Nucleotide Polymorphism (SNP) Panels and Risk Assessment in Women Undergoing Mammography
The primary objective is to compare the predicted lifetime risk values produced by SNP panel assessment to the risk values produced by the prediction models that are most commonly used. A second objective is to examine whether the incorporation of risk assessment panels (standard or SNP based) can improve the positive value of breast biopsies in women with BIRADS 4 mammograms.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||SNP Panels and Risk Assessment in Women Undergoing Mammography|
- Predicted Risk Category and Prevention Recommendations [ Designated as safety issue: No ]The predicted risk category and prevention recommendations which are based upon the category each patient falls into after risk assessment using either a traditional or a SNP-based approach. Change in PPV of mannographic biopsy by stratification into low and high risk groups.
- Tests and Evaluations [ Designated as safety issue: No ]Secondary Outcome will be determining the number of women who are ordered and/or complete tests and/or evaluations if there are abnormal imaging results during mammography or if they have high lifetime risk. These will be measured through access to the electronic medical records (EMR) and/or through a follow up survey.
|Study Start Date:||February 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
A random sample of 600 women undergoing screening mammography
BIRADS score of 4
An additional 600 women determined to have a Breast Imaging Reporting and Data System (BIRADS) score of 4 as determined by final mammogram results.
Calculating the risk that a woman will develop breast cancer in her lifetime can lead to decreased mortality rates as a result of increased screening and prevention methods when a person is known to be at high risk. Though there are several risk assessment models that are commonly used, it is important to continue to improve the process of calculating risk. Several genetic markers have been noted to potentially indicate risk of developing breast cancer. New tests, called SNP panels, can detect some of these genetic markers. This study aims to use both these SNP panels and the commonly used risk models to calculate risk and examine outcomes in women coming in to do screening mammography. This study will enroll women between the ages of 40-65 who are undergoing screening mammography (n=1000), in addition to women with BIRADS category 4 mammogram readings who are about to undergo biopsy (n=600), all with no personal history of breast or ovarian cancer, ductal carcinoma in situ (DCIS), mantle radiation, or known BRCA 1/2/mutation in self or family members. The participants will only be expected rto provide consent, swabs of the inside of the cheek of her mouth, and baseline questionnaire answers that will allow for a risk assessment to be performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124019
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Susan Domchek, MD||Abramson Cancer Center of the University of Pennsylvania|