NCT06322238 Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:
| NCT ID | NCT06322238 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Pharmacogenomic Drug Interaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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').
Eligibility Criteria
Inclusion 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
Contact & Investigator
Isa Houwink, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06322238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pharmacogenomic Drug Interaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06322238 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06322238 currently recruiting?
Yes, NCT06322238 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT06322238 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06322238 clinical trial?
NCT06322238 is sponsored by Mayo Clinic. The principal investigator is Isa Houwink, M.D., Ph.D. at Mayo Clinic. The trial plans to enroll 66 participants.