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

Overview

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.

Full Title of Study: “Precision Pharmacogenomics in Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 6, 2022

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.

Interventions

  • Procedure: Biospecimen Collection
    • Undergo collection of saliva
  • Other: Genetic Testing
    • Undergo pharmacogenomics testing
  • Other: Quality-of-Life Assessment
    • Ancillary studies
  • Other: Questionnaire Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Screening (pharmacogenomics testing)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Niloy Jewel (Jewel) Samadder, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Niloy J Samadder, Principal Investigator, Mayo Clinic

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