Evaluating drug reactions in patients taking multiple medications using genome sequencing
The Texas A&M Interprofessional Pharmacogenomics PILOT Whole Genome Sequencing (WGS) Cohort
Texas A&M University · NCT06766071
This study is testing if using genetic information can help doctors better manage medications and reduce bad reactions in patients taking five or more drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Texas A&M University (other) |
| Locations | 1 site (Bryan, Texas) |
| Trial ID | NCT06766071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess adverse drug reactions (ADRs) in patients who are on five or more medications, utilizing advanced pharmacogenomic technology. The research will analyze genetic data to optimize medication regimens and develop a clinical decision support dashboard to identify necessary changes in drug therapies. Additionally, the study will evaluate the capacity of CYP P450 enzymatic pathways in these patients and assess the feasibility of integrating genomic data into clinical workflows. The ultimate goal is to enhance patient safety and medication management in polypharmacy scenarios.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-100 who are taking five or more medications, including over-the-counter drugs and supplements.
Not a fit: Patients with certain liver diseases, cancer diagnoses, or those who are admitted to hospice may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective medication regimens for patients with complex medication needs.
How similar studies have performed: While there have been various medication management programs, this approach utilizing whole genome sequencing for polypharmacy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals 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 and blood samples, and undergo a comprehensive history and physical examination. * All genders * Age 18-100 Exclusion Criteria: * 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 or related dementias in a medical record indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning. * Pregnant patients will be excluded. * Individuals who are unable or unwilling to provide consent will be excluded. * Unable to verbally communicate and comprehend English language.
Where this trial is running
Bryan, Texas
- Texas A&M Family Care — Bryan, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Kenneth S Ramos,, MD
- Email: kramos@tamu.edu
- Phone: 7136777740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adverse Drug Reaction, Polypharmacy Patients, whole genome sequencing