Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06766071

The Texas A&M Interprofessional Pharmacogenomics PILOT Whole Genome Sequencing Cohort A Study on Adverse Drug Reactions in Patients Taking Multiple Medications

Led by Texas A&M University ยท Updated on 2025-01-09

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating adverse drug reactions (ADRs) linked to polypharmacy in patients taking multiple medications. This pilot study aims to use advanced pharmacogenomic technology to understand how genetic differences affect drug responses and to optimize medication plans. The study also investigates how the liver's CYP P450 enzyme pathways handle multiple drugs and tests the feasibility of integrating genetic data, electronic health records, and clinical workflows using whole genome sequencing (WGS). Participants taking five or more medications, including over-the-counter drugs and supplements, will be studied. The research involves collecting genetic data through buccal swabs and blood samples, as well as urine samples. Data will be used to develop and improve an electronic decision support dashboard to help healthcare providers identify and adjust problematic drug regimens. The study compares genotyping tests with research-use-only WGS, though WGS results will not be shared with patients or providers. During the 180-day study, participants will undergo comprehensive history and physical exams, provide various biological samples, and have their medication responses monitored. Researchers will track pharmacogenomic profiles and related adverse drug reactions to better understand individual drug metabolism and improve personalized medication management. The goal is to enhance patient safety and treatment effectiveness in those managing multiple medications.

CONDITIONS

Official Title

IPGx PILOT Whole Genome Sequencing Extension Cohort

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals taking 5 or more medications, including over-the-counter drugs, supplements, natural products, cannabis products, or recreational drugs
  • Ability to understand and provide consent
  • Consent to donate urine, genetic (buccal swab), and blood samples, and undergo a full history and physical exam
  • All genders eligible
  • Age between 18 and 100 years
Not Eligible

You will not qualify if you...

  • Diagnosed or treated for any cancer other than basal cell cancer in the last 5 years; metastatic melanoma in last 5 years excluded
  • Currently admitted to hospice care
  • History of Hepatitis B or C infection
  • Active liver disease or abnormal liver function tests (Meld score >10, ALT or AST >100 U/L, AST/ALT ratio >2)
  • Taking imidazole antifungal medication
  • Declines to participate or share medical information with staff
  • Diagnosis of Alzheimer's disease or related dementias
  • Pregnant individuals
  • Unable or unwilling to provide consent
  • Unable to verbally communicate or understand English language

AI-Screening

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Trial Site Locations

Total: 1 location

1

Texas A&M Family Care

Bryan, Texas, United States, 77802

Actively Recruiting

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Research Team

K

Kenneth S Ramos,, MD

R

Rick Silva, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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