GeneScreen 5-FU Genotype-guided Personalised Fluoropyrimidine Dosing: Feasibility and Implementation Pilot Study

Not Applicable

Recruiting

• Conditions: DPYD variant; Cancer - Any cancer; chemotherapy toxicity; cancer

• Registration Number: ACTRN12622000963729
• Lead Sponsor: Clinician- Prof Stephen Ackland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-07
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

18 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 Criteria

Not willing to provide consent or blood sample

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
turn around time collected through audit of study records [time from receipt of sample at pathology to return of results to clinician]

Secondary Outcome Measures

Name	Time	Method
Toxicity through audit of study records <br>[Toxicities recorded from first 3 cycles Fluoropyrimidine chemotherapy ];Implementation factors, extracted from completed questionnaires specifically designed for this study. Factors will include perceived barriers and enablers surrounding DPYD genotyping as obtained from semi-quantitative questionnaires, and attitudinal scales. <br>This is a composite endpoint<br>[Patient participants to complete 1-2 months after DPYD education and blood collection (to allow time for return of/discussion of results)<br>Stakeholder questionnaires completed at beginning of site recruitment ]