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IPGx PILOT Whole Genome Sequencing Extension Cohort

Recruitingn/aAges 18 Years - 100 YearsAllTexas A&M University
NCT06766071 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 including Whole Genome Sequencing (WGS).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Texas A&M Family Care
Bryan, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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