The Texas Interprofessional Pharmacogenomics (IPGx)

NCT06219720 | Recruiting DMC

• 1 other identifier: IRB2021-0860F
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator's primary aim is to evaluate polypharmacy-associated adverse drug reactions (ADR) in a pilot study of at-risk patients using state-of-the-art pharmacogenomic technology and to use this information to make recommendations for optimization of pharmacotherapy regimens. The data from the pilot cohort will be used to optimize and integrate a customized electronic decision support (clinical semantic network; CSN) dashboard to identify drug regimens that should be modified, replaced, or discontinued. A secondary objective of the pilot study is to evaluate the capacity/saturation of CYP P450 enzymatic pathways in polypharmacy patients. A third objective is to determine the feasibility of the planned informatics workflows between the CLIA lab, the EMR, and the Family Medicine Practice.

Conditions

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 ADRs using the Naranjo Scale (19) will be conducted for the duration of the study.

  180 days

Secondary Outcomes (5)

• Emergency department visits

  180 days

• Hospital admissions

  180 days

• Serum/plasma drug concentrations

  180 days

• Pharmacogenomic genotype with corresponding ADR phenotype

  180 days

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

  180 days

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study plans to recruit at most 50 volunteers from the Texas A\&M affiliated community health family medicine program.

You may qualify if:

• People taking 5 or more medications, including over the counter drugs, supplements, natural products, cannabis produces, or other recreational drugs
• Ability to give and comprehend the consent process.
• Consent to donate urine samples, genetic data through buccal swabs, undergo a comprehensive history and physical examination.
• All genders.
• Age 45 and over

You may not qualify if:

• Subject has been diagnosed or is being treated for any cancer other than basal cell cancer in the last 5 years. Patients with metastatic melanoma in the last 5 years will be excluded.
• Admitted to hospice.
• Patient has ever been diagnosed with Hepatitis B or C.
• Patient has ever been diagnosed with active liver disease, hepatomegaly, grossly abnormal liver function. Meld score \>10, ALT or AST \>100U/L or an AST/ALT ratio \>2
• Patients taking imidazole antifungal medication.
• Declines to participate or interact with staff/share their medical status.
• A diagnosis of Alzheimer's disease
• Pregnant patients will be excluded
• Unable/unwilling to consent.
• Unable to verbally communicate and comprehend English/Spanish language.

Sponsors & Collaborators

• Texas A&M University: lead
• InnovativeGx: collaborator
• Texas A&M Health Family Care Clinic: collaborator
• iC42 Clinical Research and Development: collaborator
• Goldblatt systems: collaborator

Study Sites (1)

The Interprofessional Pharmacogenomics (IPGx) Clinic

Bryan, Texas, 77802, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

a urine sample and cheek swab

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Kenneth S Ramos, MD

  Texas A&M IBT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth S Ramos, MD

CONTACT

7136777740; kramos@tamu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 23, 2024
• Study Start: December 15, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

US (1)