Actively Recruiting
The Texas A&M Interprofessional Pharmacogenomics PILOT Whole Genome Sequencing Cohort for Polypharmacy Patients and Adverse Drug Reactions
Led by Texas A&M University ยท Updated on 2025-01-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adverse drug reactions (ADRs) related to taking multiple medications (polypharmacy) in patients at risk, using advanced pharmacogenomic technology. The study aims to improve medication management by integrating genomic data into electronic decision support tools. It also seeks to assess the activity of liver enzymes involved in drug metabolism and test the feasibility of combining whole genome sequencing data with electronic medical records and clinical workflows. Participants will be observed using pharmacogenomic tests, including genotyping and research-use-only whole genome sequencing, alongside comprehensive clinical assessments. The study will develop and refine a clinical decision support dashboard to help identify medication regimens that may need adjustment, replacement, or discontinuation. The research involves collecting genetic, urine, and blood samples and linking this information with patient medical histories and medication use patterns. During the study, participants will provide samples and undergo history and physical examinations. Researchers will track adverse drug reactions and emergency department visits over 180 days. The study will monitor pharmacogenomic genotypes paired with ADRs, using data to improve personalized medication guidance. Participants' safety and medication responses will be closely followed, with results aimed at supporting better care decisions in polypharmacy management.
CONDITIONS
Brief Title
IPGx PILOT Whole Genome Sequencing Extension Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals taking 5 or more medications, including over-the-counter drugs, supplements, natural products, cannabis products, or other recreational drugs
- Ability to give and comprehend the consent process
- Consent to donate urine samples, genetic data through buccal swabs and blood samples, and undergo a comprehensive history and physical examination
- All genders
- Age 18 to 100 years
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 the last 5 years
- Admitted to hospice
- History of Hepatitis B or C infection
- Active liver disease, hepatomegaly, or grossly abnormal liver function (Meld score >10, ALT or AST >100U/L, or AST/ALT ratio >2)
- Taking imidazole antifungal medication
- Declines to participate or share medical status with staff
- Diagnosis of Alzheimer's disease or related dementias
- Pregnant patients
- Unable or unwilling to provide consent
- Unable to verbally communicate and comprehend English language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants provide samples including urine, blood, and buccal swabs and undergo a comprehensive history and physical examination to gather pharmacogenomic and medication data.
1 visit (in-person)
Duration - 180 days
Participants are observed for up to 180 days to monitor pharmacogenomic genotypes, adverse drug reaction phenotypes, and emergency department visits related to polypharmacy.
Periodic monitoring without required visits
Trial Site Locations
Total: 1 location
1
Texas A&M Family Care
Bryan, Texas, United States, 77802
Actively Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here