Interprofessional Pharmacogenomics (IPGx) Registry and Repository

Recruiting

• Conditions: Adverse Drug Reaction (ADR); Poly Pharmacy; Diabetes; Cholesterol; Cancer; Blood Pressure Disorders; Heart Disease; Respiratory Ilness; COPD

• Registration Number: NCT06726590
• Lead Sponsor: Texas A&M University

Brief Summary

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

Detailed Description

This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study.

study goals include:

* Enrolling patients who take multiple medications or have harmful side effects from their medications.

* Keeping all medical information and genetic samples from patients in one place.

* Helping doctors make better decisions about which medicines to prescribe.

* Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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.
• Able to answer detailed questionnaires, including quarterly questionnaires about ADRs, cognitive testing such as serial mini-mental status exams, and or quality of life questions.
• Able to understand that their health record and changes in health status will be followed for a five-year period and shared in deidentified form with the research community.
• All genders.
• Any age over 18 years.

Exclusion Criteria

• 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.
• Unable to verbally communicate and comprehend English language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency and nature of ADRs on the Naranjo Scale	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Serum/plasma drug concentrations	5 years	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.

Trial Locations

Locations (1)

Texas A&M Family Care; 🇺🇸 Bryan, Texas, United States