Single Nucleotide Polymorphism (SNP) Panels and Risk Assessment in Women Undergoing Mammography

NCT01124019 | Completed

• 1 other identifier: UPCC 17109
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mammography

Keywords

Women undergoing screening mammography will be chosen if they are between the ages of 40 and 65.

Outcome Measures

Primary Outcomes (1)

• Predicted Risk Category and Prevention Recommendations

  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.

Secondary Outcomes (1)

• Tests and Evaluations

Study Arms (2)

Random Sample

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.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult women will be recruited for this study. Women undergoing screening mammography will be chosen if they are between the ages of 40 and 65. 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Susan Domchek, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

US (1)