Personalized testing to reduce dangerous side effects from the chemotherapy drug 5‑FU

A precision medicine approach to improve prediction of severe toxicity in fluorouracil chemotherapy

['FUNDING_R01'] · UNIVERSITY OF IOWA · NIH-11249531

This project aims to create better pre-treatment tests to find cancer patients at high risk of severe reactions to the common chemotherapy drug 5‑FU.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorUNIVERSITY OF IOWA (nih funded)
Locations1 site (IOWA CITY, UNITED STATES)
Trial IDNIH-11249531 on ClinicalTrials.gov

What this research studies

Many people receiving 5‑FU chemotherapy get severe, sometimes life‑threatening side effects because they have reduced activity of an enzyme called DPD that breaks down the drug. Current genetic tests look at only four DPYD gene variants and miss many at‑risk patients, particularly those who are not of European ancestry. The research team will search for additional genetic and blood‑based biomarkers and combine them into expanded pre‑treatment tests that estimate how much DPD function a person has. The goal is to use that information to personalize 5‑FU dosing so patients can get effective cancer treatment with fewer dangerous side effects.

Who could benefit from this research

Good fit: People who are about to start 5‑FU (fluorouracil) chemotherapy for cancer—especially patients from underrepresented ancestry groups such as African American patients—would be the most relevant candidates.

Not a fit: Patients who are not receiving 5‑FU, whose toxicity arises from non‑DPD causes, or who are already treated with safe alternative regimens may not benefit directly from this work.

Why it matters

Potential benefit: If successful, doctors could better identify patients at risk and adjust 5‑FU doses to prevent severe and life‑threatening toxicities.

How similar studies have performed: Previous work validated four DPYD variants that predict some 5‑FU toxicity but these explain only a small fraction of cases and perform poorly outside European ancestry, so this project builds on existing findings to broaden and improve prediction.

Where this research is happening

IOWA CITY, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.