Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06766071

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

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 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
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 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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