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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
Sponsor: Rutgers, The State University of New Jersey
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-08-27
Completion Date
2029-07-07
Last Updated
2025-11-13
Healthy Volunteers
No
Conditions
Interventions
Fluorouracil injection
Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
Xeloda
Experimental arm Fluorouracil injection with possible escalation to 75 or 100 percent if tolerated.
Locations (12)
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospita
New Brunswick, New Jersey, United States
Cancer Center Initiative
Newark, New Jersey, United States
University Hospital
Newark, New Jersey, United States
RWJBarnabas Health Newark Beth Israel Medical Center
Newark, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States