RecruitingNCT06766071

IPGx PILOT Whole Genome Sequencing Extension Cohort

The Texas A&M Interprofessional Pharmacogenomics PILOT Whole Genome Sequencing (WGS) Cohort


Sponsor

Texas A&M University

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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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Locations(1)

Texas A&M Family Care

Bryan, Texas, United States

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NCT06766071


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