Pre-treatment dihydropyrimidine dehydrogenase (DPYD) genotyping in patients receiving fluoropyrimidine (5-Fluorouracil or Capecitabine) chemotherapy: A clinical implementation study of the effect of individualised dosing on treatment related toxicity

Not Applicable

Recruiting

• Conditions: cancer; Cancer - Other cancer types

• Registration Number: ACTRN12621001117808
• Lead Sponsor: Queensland Health - Metro North Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-23
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

a.Pathologically confirmed malignancy for which treatment with a fluoropyrimidine at full dose (with or without other chemotherapy agents or radiation) is deemed clinically appropriate
b.Adult patient (> 18 years)
c.Receiving their first dose of fluoropyrimidine (either as a single agent or in combination) between 1 July, 2021 and 30 June, 2022.
d.Willing to provide blood sample for pharmacogenetic testing

Exclusion Criteria

a.Inability to provide informed consent
b.Prior use of fluoropyrimidines
c.Women who are pregnant or breast-feeding
d.Patients with a previously known homozygous polymorphic genotype or compound heterozygous genotype for DPYD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe treatment related toxicity (CTC grade 3 or higher) within 60 days of a patient beginning fluoropyrimidine treatment.[Within 60 days of beginning treatment]

Secondary Outcome Measures

Name	Time	Method
nplanned hospital admissions related to treatment within 60 days of a patient beginning fluoropyrimidine treatment will be reviewed from the patients electronic medical record.[Within 60 days of a patient beginning fluoropyrimidine treatment];Rates of fluoropyrimidine dose intensity during the first 60 days of beginning fluoropyrimidine treatment will be reviewed from the patients electronic medical record[At the conclusion of the study];Documented practical clinical implementation issues including testing timeframes. This will be assessed via an audit of study records and liaison with Pathology completing the testing. [At the conclusion of the study ];Rates of fluoropyrimidine dose delays during the first 60 days of beginning fluoropyrimidine treatment will be reviewed from the patients electronic medical record[At the conclusion of the study ]