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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2, 2025 to Aug 27, 2025
    • Eligibility criteria shortened, about 8 words
    • Site details revised at 12 of 12 sites
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.
Trial Details
NCT Number NCT07158164
Lead Sponsor Rutgers, The State University of New Jersey
Conditions
(from sponsor)		 Colorectal Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Gastro-Intestinal Intraepithelial Neoplasia
Related terms Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov