Interprofessional Pharmacogenomics (IPGx) Registry and Repository

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTexas A&M University

About this trial

This program collects genetic and health information to help doctors choose the right medications for patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study will invite patients who are eligible for PGX workup/PGX care to participate, provided they meet the following criteria: Use of five or more medications, including over the counter drugs, supplements, natural products, cannabis products, or other recreational drugs, or

Individuals taking blood pressure or depression medications, even if less than five medications.

Ability to understand and give consent.

Able to consent to donate blood and/or urine samples and buccal swabs.

Disqualifiers

Individuals admitted to hospice.

Declines to participate or interact with staff/share their medical status.

A diagnosis of Alzheimer's disease or related dementias in a medical record as this indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.,

Individuals who are unable or unwilling to provide consent.

Trial population

Texas A\&M Health clinical programs.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 1 trial group
Group A: Polypharmacy

Trial outcomes

Primary outcomes

1

Frequency and nature of ADRs on the Naranjo Scale

Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians. A physician or ambulatory pharmacist in the IPGx clinic or Family Care Clinic will obtain a complete medical history, physical examination, and validate the patient's current concomitant medication list at the IPGx during the office visit. Patient medical information would be input into the CSN, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of Adverse Drug Reactions using the Naranjo Scale questionnaire will be conducted for the duration of the study.

Time frame
5 years

Secondary outcomes

1

Serum/plasma drug concentrations

Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians for an evaluation of pharmacokinetic and pharmacodynamic (PK/PD) assessments. For drug level measurement, urine samples will be collected using provided kits and shipped to the contracted laboratory via FedEx in biosafety shipping containers.

Time frame
5 years

Other outcomes

1

Pharmacogenomic genotype with corresponding ADR phenotype

Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians to evaluate genotyping and ADR. Clinical staff will obtain a buccal swab to collect DNA for a pharmacogenomic evaluation pursuant to the sample collection kits from the CLIA lab, which will occur at the start of the study period.

Time frame
5 years
2

Drug-drug interactions, drug gene interactions, drug-drug-gene interactions

An assessment at the IPGx begins with a consultation by a pharmacist or physician. They will evaluate the medications and other drugs the patient is currently using, identifying any potential issues related to toxicity, drug interactions, or side effects that may be relevant to the patient's clinical presentation.

Time frame
5 years

Sponsors and contacts

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