SNP Panels and Risk Assessment in Women Undergoing Mammography
40 Years
65 Years
Female
Mammography
Trial Information
SNP Panels and Risk Assessment in Women Undergoing Mammography
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.
Inclusion Criteria:
- Women between the ages of 40 and 65 years old undergoing screening mammography at the
University of Pennsylvania Health System and women undergoing biopsy as the result of
a BIRADS category 4 mammogram result.
Exclusion Criteria:
- Women will be excluded if they have a personal history of breast or ovarian cancer,
DCIS, or mantle radiation, or known BRCA 1/2 mutation in self or in family members.
- In addition, women younger than 40 or older than 65 will be excluded if they are in
the screening mammography population of potential participants.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Predicted Risk Category and Prevention Recommendations
Outcome Description:
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.
Safety Issue:
No
Principal Investigator
Susan Domchek, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Institutional Review Board
Study ID:
UPCC 17109
NCT ID:
NCT01124019
Start Date:
February 2010
Completion Date:
Related Keywords:
- Mammography
- Women undergoing screening mammography will be chosen if they are between the ages of 40 and 65.
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
