Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

Description

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').

Conditions

Pharmacogenomic Drug Interaction, Side Effect of Drug, Ineffective Drug Action, Drug Metabolism, Poor, CYP2D6-Related, Drug Metabolism, Poor, CYP2C19-Related

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Study Overview

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Study Details

Study overview

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').

A Multi-gene Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: Open-label, Mayo Clinic Multisite (Mankato-Rochester Primary Care), Controlled, Implementation Study Taking the Results of the PREPARE Study Into Minnesota (PREPARE-Mayo)

Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

Condition
Pharmacogenomic Drug Interaction
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • *
  • 1. For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
  • 2. Pregnant or lactating (to be verbally confirmed with the patient)
  • 3. Life expectancy estimated to be less than three months as determined by patient receiving hospice care
  • 4. Duration of index drug total treatment length is planned to be less than seven consecutive days.
  • 5. Current inpatients
  • 6. Unable to consent to the study
  • 7. Unwilling to take part
  • 8. Subject has no permanent address
  • 9. Subject has no current primary care provider
  • 10. Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
  • 11. Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
  • 12. Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
  • 13. History of a liver transplant or an allogeneic hematopoietic stem cell transplant
  • 14. DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mayo Clinic,

Isa Houwink, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2027-04