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SNP Panels and Risk Assessment in Women Undergoing Mammography


N/A
40 Years
65 Years
Open (Enrolling)
Female
Mammography

Thank you

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