Interprofessional Pharmacogenomics (IPGx) Registry and Repository

NCT06726590 | Recruiting DMC

• 1 other identifier: STUDY2023-0042
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

REGISTRY; REPOSITORY; POLYPHARMACY; ADVERSE DRUG REACTION

Outcome Measures

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.

  5 years

Secondary Outcomes (1)

• Serum/plasma drug concentrations

  5 years

Other Outcomes (2)

• Pharmacogenomic genotype with corresponding ADR phenotype

  5 years

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

  5 years

Study Arms (1)

Polypharmacy

Patients taking many medications or medications with severe side effects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Texas A\&M Health clinical programs.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M Family Care

Bryan, Texas, 77802, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, and cheek cells

MeSH Terms

Conditions

Diabetes Mellitus; Neoplasms; Heart Diseases; Pulmonary Disease, Chronic Obstructive; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Central Study Contacts

Kenneth S Ramos, MD, PhD

CONTACT

(713) 677-7440; kramos@tamu.edu

Rick Silva, PhD

CONTACT

ricksilva@tamu.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 10, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 12, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)