GeneScreen 5-FU Genotype-guided Personalised Fluoropyrimidine Dosing: Feasibility and Implementation Pilot Study
GeneScreen 5-FU Genotype-guided Personalised Fluoropyrimidine Dosing: Feasibility and Implementation Pilot Study in Adults with Solid Cancer Tumours
Clinician- Prof Stephen Ackland
100 participants
Jan 19, 2021
Interventional
Conditions
Summary
The aim of this study is to investigate if testing for the DPYD gene in patients is practical and useful, for the purpose of providing personalised dosing of chemotherapy treatment Fluoropyrimidine (FP; 5FU, Capecitabine). Who is it for? You may be eligible to join this study if you are aged 18 years or older; and have or will be receiving Fluoropyrimidine chemotherapy treatment. Study details All patients will be asked to provide a blood sample, and the blood sample will be tested for the DPYD gene. The result will be shared with the patient's doctor, and whether this affects the patient's chemotherapy treatment or not will be decided by the patient's doctor. Additionally, patients and medical professionals will also be invited to do a questionnaire exploring the perceived knowledge and attitudes toward genetic testing for DPYD. It is hoped that this study will reveal if screening for the DPYD gene can be used to inform personalised chemotherapy dosing, and understand factors that affect this process, to be able to provide better care to cancer patients.
Eligibility
Inclusion Criteria3
- years and older
- Intended to receive, currently receiving or recently received Fluoropyrimidine chemotherapy (either capecitabine or 5-fluorouracil)
- Able to consent for a blood test +/- questionnaire invitation
Exclusion Criteria1
- Not willing to provide consent or blood sample
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Interventions
Adult patients with solid organ tumours intended to or already undertaking Fluoropyrimidine chemotherapies are eligible for inclusion. Patients submit a blood sample to be collected either by phlebotomy trained nurse or usual blood collection facility) for DPYD genotyping to identify DPYD variants that carry important clinical significant for fluoropyrimidine related toxicity. Samples are genotyped and results provided back to oncologist. This is a feasibility study measuring turn around time of testing. Any decisions regarding DPYD variant results are at clinician discretion. Patients and clinical stakeholders (Oncology clinicians, oncology pharmacists and oncology nurses) are invited to participate in a questionnaire exploring the perceived knowledge and attitudes toward upfront DPYD genotyping. We also explore the enablers and barriers that contribute to upfront testing as perceived by questionnaire respondents.
Locations(4)
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ACTRN12622000963729