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IPGx PILOT Whole Genome Sequencing Extension Cohort

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later Jan 2026 → Jan 2029
See other at-risk trials from Texas A&M University

Record History

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  1. Notable Primary and study completion pushed from Jan 2026 to Jan 2029 Show 5 more changesShow less
    • Lead sponsor: Texas A&M University to Texas A&M University
    • Start date: Jan 2025 to Dec 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06766071
Lead Sponsor Texas A&M University
Conditions
(from sponsor)
Adverse Drug Reaction (ADR), Polypharmacy Patients
Related terms Drug-Related Side Effects and Adverse Reactions
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov