IPGx PILOT Whole Genome Sequencing Extension Cohort

Recruiting now

Conditions studied: Adverse Drug Reaction (ADR), Polypharmacy Patients

In brief

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).

Key facts

Study ID

NCT06766071

Run by

Texas A&M University

People needed

50

Starts

2025-01-01

Expected to finish

2026-01-01

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Texas A&M Family Care — Bryan, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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