NCT03067389

Combined Breast Cancer Risk Study

Evaluation of a Combined Breast Cancer Risk Derived From a Polygenic Risk Score and the Tyrer-Cuzick Model

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 553 (actual)
• Sponsor: Myriad Genetic Laboratories, Inc. · Industry
• Sex: Female
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hereditary Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic test	Genetic diagnostic test

Timeline

• Start date: 2016-02-06
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2017-03-01
• Last updated: 2019-01-15

Locations

4 sites across 1 country: United States