Malignant Solid Neoplasm Clinical Trial
Official title:
Precision Pharmacogenomics in Cancer Patients
| Verified date | July 2023 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 197 |
| Est. completion date | October 6, 2022 |
| Est. primary completion date | October 6, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing | Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing. | Baseline up to 3 months post consent | |
| Secondary | Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients | Will qualitatively assess provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients via the provider survey. Provider survey responses will be examined to determine the range of perceptions and experiences associated with PGx testing and result reporting for patient tests. Descriptive statistics will be used to report provider survey results. | Up to 3 months |
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