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NCT07158164 · ClinicalTrials.gov registry record · Phase 4

DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

A Phase 4 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by Rutgers, The State University of New Jersey.

Recruiting
Registry status
Phase 4
Development phase
100
Enrollment target
12
Study locations

NCT07158164 is a Phase 4 study of Breast Neoplasms and Colorectal Neoplasms that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 100 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (82% lower). The trial reports 12 study locations across 1 state.

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The verdict

NCT07158164, a Phase 4 study of Breast Neoplasms and Colorectal Neoplasms, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.

RECRUITING
Registry status
Phase 4
Development phase
100 participants
Enrollment target
12
Study locations

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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2025-08-27
Est. Completion 2029-07-07
Phase Phase 4

What the Registry Record Tells You About NCT07158164

The ClinicalTrials.gov registry entry for NCT07158164 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (82% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.

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.

NCT07158164 reports 12 study locations spanning 1 distinct geographic area - top geographies include New Jersey.

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.

What interventions are being tested in trial NCT07158164?

The interventions under investigation include: Xeloda (DRUG), Fluorouracil injection (DRUG).

Who is sponsoring clinical trial NCT07158164?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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