Using genetic testing to prevent adverse drug reactions in primary care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to implement pre-emptive pharmacogenomic testing to guide the selection and dosing of 39 commonly prescribed medications. By analyzing a panel of clinically relevant pharmacogenomic markers, the study seeks to reduce the occurrence of adverse drug reactions (ADRs) associated with specific medications. Participants will be followed for 48 weeks to assess the effectiveness of this approach in a primary care setting. The study focuses on patients receiving their first prescription for these drugs and involves saliva donation for genetic analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Isa Houwink, M.D., Ph.D. — Mayo Clinic

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.