IPGx PILOT Whole Genome Sequencing Extension Cohort

Part of paid clinical trials in Bryan, Texas.

Sponsor
Texas A&M University
Study ID
NCT06766071
Status
Recruiting
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Conditions

  • Adverse Drug Reaction (ADR)
  • Polypharmacy Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Jan 31, 2025
Status verified
Sep 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

Pharmacogenomic genotype with corresponding ADR phenotype [ Time Frame: 180 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas A&M Family CareBryanTexas77802
Gabriel Neal, MD
[email protected]
979-436-0399
Sara Rogers, PharmD
[email protected]
979 436 0286
Kenneth S Ramos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Rick Silva, PhD (SUB_INVESTIGATOR)
Sara Rogers, PharmD (SUB_INVESTIGATOR)
George Udeani, PharmD (SUB_INVESTIGATOR)
Fen Wang, PhD (SUB_INVESTIGATOR)
Marcia Ory, PhD (SUB_INVESTIGATOR)

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