A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.
This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.
Study Type
OBSERVATIONAL
Enrollment
553
Genetic diagnostic test
The Breast Center of Northwest Arkansas
Fayetteville, Arkansas, United States
Bethesda Health
Boynton Beach, Florida, United States
Cuda Women's Health Center
Hyannis, Massachusetts, United States
Elizabeth Wende Breast Care
Rochester, New York, United States
To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone
Time frame: Baseline
To derive a distribution of polygenic risk scores in an unselected patient population
Time frame: baseline
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