Precision Pharmacogenomics in Cancer Patients
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8
- Sponsor
- Mayo Clinic
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing. II. Understand the clinical utility/relevancy of PGx testing in cancer patients at Mayo Clinic Arizona from the viewpoint of their providers. OUTLINE: Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing. After completion of study, patients are followed for up to 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient enrolled to Mayo Clinic IRB: 18-000326
- •Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreato-biliary, brain, melanoma, and ovarian cancer
- •Individuals have agreed to participate and signed the study informed consent form
Exclusion Criteria
- •Patients with cancer types other than the ones mentioned above
- •Patient with psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
- •Previous PGx testing with results available within Mayo Clinic electronic medical record (EMR)
Outcomes
Primary Outcomes
Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
Time Frame: Baseline up to 3 months post consent
Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.
Secondary Outcomes
- Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients(Up to 3 months)