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RecruitingLast updated: 16 December 2025

GeneScreen 5-FU: This study aims to identify the best way to implement chemotherapy in people with cancer who have a genetic variant of the DPYD gene, as well as the ability to test for UGT1A1 prior to chemotherapy, and the cost-effectiveness of a large-scale roll out of this screening programDPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Solid Organ Cancer Patients

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

GeneScreen 5-FU

Clinical summary

Summary

All participants who meet the eligibility criteria in this study will undergo pharmacogenomic genotyping to identify DPYD and UGT1A1 variants prior to beginning fluoropyrimidine (FP) and irinotecan (IRI) (where applicable) chemotherapies.

Genotyping is conducted from a blood sample collected from participants prior to beginning chemotherapy, and relevant adjustments to chemotherapy dosing is made in accordance with international dosing guidelines.

Participants will be followed for 60 days to assess for acute chemotherapy induced toxicity, and beyond completion of chemotherapy regimen to assess cost-effectiveness and feasibility of the screening program. No additional tests will be requried from participants beyond standard of care.

It is hoped that this research project will determine the feasibility of DPYD genetic testing for cancer patients which may assist with providing personalised treatment options for these patients. 

Conditions

This trial is treating people with solid cancers who require fluoropyrimidine chemotherapy

Eligibility

Inclusion

Minimum 18 years old
Solid organ malignancy requiring fluoropyrimidine chemotherapy (+/- irinotecan for UGT1A1 genotyping)
Able to provide informed consent
Able to provide blood sample

Exclusion

Prior fluoropyrimidine exposure
Pregnant or breastfeeding women
Unwilling to provide consent and/ or blood sample

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Hunter Medical Research Unit

Scientific Title

DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Solid Organ Cancer Patients

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