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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04067960
Collaborator
National Cancer Institute (NCI) (NIH)
250
Enrollment
1
Location
54.8
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Genetic Testing
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

  1. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing.

  2. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Precision Pharmacogenomics in Cancer Patients
Actual Study Start Date :
Jun 6, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Ancillary-correlative (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.

Procedure: Biospecimen Collection
Undergo collection of saliva

Other: Genetic Testing
Undergo pharmacogenomics testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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 (analyzed qualitatively) across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.

    Secondary Outcome Measures

    1. 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 (analyzed qualitatively) 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 Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patient enrolled to Mayo Clinic IRB: 18-000326

    • Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreatic, 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Niloy J Samadder, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04067960
    Other Study ID Numbers:
    • 19-002006
    • NCI-2019-04725
    • 19-002006
    • P30CA015083
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Prostatic Neoplasms
    Neoplasms
    Colorectal Neoplasms
    Melanoma
    Pancreatic Neoplasms
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Skin Neoplasms
    Brain Neoplasms

    Study Results

    No Results Posted as of Feb 7, 2022