Breast Cancer Clinical Trial

Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer

Summary

This study aims to assess how a polygenic risk score (PRS) reported with the results of multi-gene panel testing affects the breast cancer risk management recommendations healthcare providers make to their patients. The PRS is a score based on small genetic changes, clinical history, and family history. The PRS is used to estimate remaining lifetime risk of developing breast cancer for patients with no personal history of breast cancer and an overall negative result from MGPT.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female, age ≥ 18 years
Willing and able to provide meaningful informed consent
Willing and able to complete study procedures as described in this protocol
Electing to undergo multi-gene panel testing for hereditary breast cancer for clinical purposes at the time of consent
No personal history of cancer (except non-melanoma skin cancer) and meets NCCN guidelines for BRCA1/2 testing based on family history of breast and/or ovarian cancer
Meets Ambry criteria for clinical reporting of PRS score

Exclusion Criteria:

Prior germline BRCA1/2 testing
Not willing to receive PRS
Personal history of cancer, except non-melanoma skin cancer
Personal history of allogenic bone marrow/stem cell transplant

Study is for people with:

Breast Cancer

Estimated Enrollment:

118

Study ID:

NCT03688204

Recruitment Status:

Completed

Sponsor:

Ambry Genetics

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There are 3 Locations for this study

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Providence Roy and Patricia Disney Family Cancer Center
Burbank California, 91505, United States
St Joseph Hospital of Orange
Orange California, 92868, United States
Edwards Comprehensive Cancer Center
Huntington West Virginia, 25701, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

118

Study ID:

NCT03688204

Recruitment Status:

Completed

Sponsor:


Ambry Genetics

How clear is this clinincal trial information?

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