GeneScreen 5-FU: DPYD Genotype-guided dose Personalisation for Fluoropyrimidine prescribing in Solid Organ Cancer Patients

Not Applicable

• Conditions: Cancer; Fluoropyrimidine chemotherapy toxicity; DPD deficiency; DPYD gene variant; UGT1A1 gene variant; Cancer - Any cancer

• Registration Number: ACTRN12623001301651
• Lead Sponsor: Hunter Medical Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-13
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FP toxicity, assessed by CTCAE v5 criteria at routine visits post first exposure, or during hospitalisations in between routine visits[ Up to 60 days post first exposure to FP chemotherapy];Cost effectiveness: health economic modelling and development of decision analytic model. Data to be collected from hospital financial records with data-linkage to the Pharmaceutical Benefits Scheme database to determine treatment costs[ immediately following collection of patient dataset]

Secondary Outcome Measures

Name	Time	Method
DPYD frequency in Australian population (carriers as a proportion of total study cohort)[ From baseline blood test];UGT1A1 feasibility: assessed as the turn around time for testing from the provision of sample to the return of results as recorded in a study-specific database[ Cumulative data assessed at the conclusion of the study];Development of metastatic disease[ Review of medical records from start of trial to 5 years post first chemotherapy ];Disease free survival [ Review of medical records from start of trial to 5 years post first chemotherapy ];Progression free survival[ Review of medical records from start of trial to 5 years post first chemotherapy ];Overall survival [ Review of medical records from start of trial to 5 years post first chemotherapy ]