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DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
NCT07158164 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Xeloda
- DRUG Fluorouracil injection
Study Locations (12)
New Jersey
- RWJBarnabas Health Clara Maas Medical Center — Belleville
- Trinitas Hospital and Comprehensive Cancer Center — Elizabeth
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton — Hamilton
- RWJBarnabas Health Jersey City Medical Center — Jersey City
- Cooperman Barnabas Medical Center — Livingston
- Jack and Sheryl Morris Cancer Center — New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospita — New Brunswick
- Cancer Center Initiative — Newark
- University Hospital — Newark
- RWJBarnabas Health Newark Beth Israel Medical Center — Newark
- RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset — Somerville
- RWJBarnabas Health - Community Medical Center — Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2029-07-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07158164
The ClinicalTrials.gov registry entry for NCT07158164 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Xeloda is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07158164 reports 12 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07158164 about?
NCT07158164 is a clinical study titled "DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment". 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 vers...
What is the current status of trial NCT07158164?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-08-27. Estimated completion is 2029-07-07.
What conditions does trial NCT07158164 study?
This clinical trial studies the following conditions: Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Gastro-Intestinal Intraepithelial Neoplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07158164?
The interventions under investigation include: Xeloda (DRUG), Fluorouracil injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07158164?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07158164 being conducted?
This trial has 12 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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