Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | September 21, 2018 |
| End Date: | September 21, 2025 |
| Contact: | Kyle J Allen, MS |
| Email: | kallen@ambrygen.com |
| Phone: | 949-457-4420 |
Clinical Implementation of a Polygenic Risk Score (PRS) for Breast Cancer: Impact on Risk Estimates, Management Recommendations, Clinical Outcomes, and Patient Perception
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.
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.
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
We found this trial at
2
sites
Burbank, California 91505
Principal Investigator: Ora Gordon, MD
Phone: 818-748-4748
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Huntington, West Virginia 25701
Principal Investigator: Lisa Muto, NP
Phone: 304-399-6572
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