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NCT Number: NCT06726590

Interprofessional Pharmacogenomics (IPGx) Registry and Repository

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

Recruiting

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Key information

Conditions

Diabetes Adverse Drug Reaction (ADR) Blood Pressure Disorders COPD Cancer Cardiovascular Diseases Chemically-Induced Disorders Cholesterol Chronic Disease Diabetes Mellitus Disease Attributes Drug-Related Side Effects and Adverse Reactions Endocrine System Diseases Glucose Metabolism Disorders Heart Disease Heart Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Poly Pharmacy Pulmonary Disease, Chronic Obstructive Respiratory Ilness Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas A&M Family Care

Bryan, Texas, 77802, United States

Location status: Recruiting

Location contact

Asim Abu-Baker, PharmD

SUB_INVESTIGATOR

Fen Wang, PhD

SUB_INVESTIGATOR

Gabriel Neal, MD

SUB_INVESTIGATOR

George Udeani, PharmD, DSC, FCP, FCCP

SUB_INVESTIGATOR

Kenneth S Kenneth S. Ramos, MD, PhD

PRINCIPAL_INVESTIGATOR

Marcia Ory, PhD

SUB_INVESTIGATOR

Rick Silva, PhD

SUB_INVESTIGATOR

Sara Rogers, PharmD

CONTACT

[email protected]

979.776.8440

Sara Rogers, PharmD

SUB_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency and nature of ADRs on the Naranjo Scale

    Time frame: 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 outcomes

  1. Serum/plasma drug concentrations

    Time frame: 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.

Other outcomes

  1. Pharmacogenomic genotype with corresponding ADR phenotype

    Time frame: 5 years

    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.

  2. Drug-drug interactions, drug gene interactions, drug-drug-gene interactions

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth S Ramos, MD, PhD

CONTACT

[email protected]

(713) 677-7440

Rick Silva, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

The Texas Interprofessional Pharmacogenomics Registry and Repository

Acronym: IPGx Registry

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 10, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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