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

NCT ID: NCT06322238

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-04-30

Brief Summary

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PGx testing arm

Group Type: EXPERIMENTAL

PGx panel test

Intervention Type: DIAGNOSTIC_TEST

In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Delayed PGx testing arm

Group Type: PLACEBO_COMPARATOR

PGx panel test

Intervention Type: DIAGNOSTIC_TEST

In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Interventions

PGx panel test

In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Subject must be ≥ 18 years old

2. Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.

3. Subject is able and willing to take part and willing to be followed up on for 48 weeks

4. Subject is able to donate saliva

5. Subject has signed informed consent

6. Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Isa J. Houwink

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Elisa Houwink, MD, PhD

Role: primary

houwink.elisa@mayo.edu

5073192037

Mary Johnson

Role: backup

johnson.mary15@mayo.edu

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

23-008706

Identifier Type: -

Identifier Source: org_study_id