Interprofessional Pharmacogenomics (IPGx) Registry and Repository (IPGx Registry)

The Texas Interprofessional Pharmacogenomics Registry and Repository

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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Kenneth S Ramos, MD, PhD; Phone Number: (713) 677-7440; Email: kramos@tamu.edu
• Study Contact Backup: Name: Rick Silva, PhD; Email: ricksilva@tamu.edu

Study Locations

• United States
  • Texas
    • Bryan, Texas, United States, 77802
      • Recruiting
      • Texas A&M Family Care
      • Sub-Investigator: Gabriel Neal, MD
      • Sub-Investigator: Sara Rogers, PharmD
      • Sub-Investigator: Asim Abu-Baker, PharmD
      • Contact: Sara Rogers, PharmD; Phone Number: 979.776.8440; Email: sararogers@tamu.edu
      • Contact: Email: gneal@tamu.edu
      • Sub-Investigator: Rick Silva, PhD
      • Sub-Investigator: Fen Wang, PhD
      • Sub-Investigator: Marcia Ory, PhD
      • Principal Investigator: Kenneth S Kenneth S. Ramos, MD, PhD
      • Sub-Investigator: George Udeani, PharmD, DSC, FCP, FCCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Texas A&M Health clinical programs.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Polypharmacy; Patients taking many medications or medications with severe side effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
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.	5 years

Collaborators and Investigators

• Sponsor: Texas A&M University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: REGISTRY; REPOSITORY; POLYPHARMACY; ADVERSE DRUG REACTION
• Additional Relevant MeSH Terms: Endocrine System Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Glucose Metabolism Disorders; Lung Diseases, Obstructive; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Diseases; Diabetes Mellitus; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: STUDY2023-0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD deidentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No