Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer

NCT04067960 — Early Phase 1, Completed, 197 participants, Mayo Clinic
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Precision Pharmacogenomics in Cancer Patients

RegistryNCT04067960
StatusCompleted
PhaseEarly Phase 1
Study typeInterventional; na, single group, masking: none, screening
Enrollment197 (Actual)
SponsorMayo Clinic (Other)
ConditionsAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Biliary Tract Carcinoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Malignant Brain Neoplasm, Malignant Genitourinary System Neoplasm, Malignant Solid Neoplasm, Pancreatobiliary Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Pancreatic Cancer, Stage IVA Prostate Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Pancreatic Cancer, Stage IVB Prostate Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
InterventionsBiospecimen Collection, Genetic Testing, Quality-of-Life Assessment, Questionnaire Administration (Procedure, other)
Datesstart 2019-06-06, primary completion 2022-10-06, completion 2022-10-06, first posted 2019-08-28, last updated 2024-08-14
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Anatomic Stage III Breast Cancer AJCC v8 All trials for Anatomic Stage IIIA Breast Cancer AJCC v8 All trials of Biospecimen Collection All trials of Genetic Testing

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Screening (pharmacogenomics testing)ExperimentalProcedure: Biospecimen Collection; Other: Genetic Testing; Other: Quality-of-Life Assessment; Other: Questionnaire AdministrationPatients 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.
  • Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Specimen Collection: Undergo collection of saliva
  • Genetic Testing (Other), also known as genetic analysis, Genetic Examination, Genetic Test: Undergo pharmacogenomics testing
  • Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Ancillary studies
  • Questionnaire Administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

  • Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing [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]: 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.

+Eligibility

Sex: All, accepts healthy volunteers

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)

+Locations (1)

FacilityCityCountryStatus
Mayo Clinic in ArizonaScottsdale, ArizonaUnited States

+Investigators