RECRUITING

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

Conditions

Pharmacogenomic Drug Interaction Side Effect of Drug Ineffective Drug Action Drug Metabolism, Poor, CYP2D6-Related Drug Metabolism, Poor, CYP2C19-Related pharmacogenomics PGx CPIC primary care drug metabolism side effects ineffectiveness PREPARE-Mayo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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').

Official Title

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)

Quick Facts

Study Start:2024-12-01

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06322238

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Isa Houwink, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55902

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01

Study Completion Date2027-04

Study Record Updates

Study Start Date2024-12-01

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

pharmacogenomics
PGx
CPIC
primary care
drug metabolism
side effects
ineffectiveness
PREPARE-Mayo

Additional Relevant MeSH Terms

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