Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000963729
Ethics application status
Approved
Date submitted
4/07/2022
Date registered
7/07/2022
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
GeneScreen 5-FU Genotype-guided Personalised Fluoropyrimidine Dosing: Feasibility and Implementation Pilot Study
Scientific title
GeneScreen 5-FU Genotype-guided Personalised Fluoropyrimidine Dosing: Feasibility and Implementation Pilot Study in Adults with Solid Cancer Tumours
Secondary ID [1] 307488 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
GeneScreen 5-FU Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 326887 0
chemotherapy toxicity 326888 0
DPYD variant 326889 0
Condition category
Condition code
Cancer 324095 324095 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323943 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331895 0
turn around time collected through audit of study records
Timepoint [1] 331895 0
time from receipt of sample at pathology to return of results to clinician
Secondary outcome [1] 411521 0
Toxicity through audit of study records
Timepoint [1] 411521 0
Toxicities recorded from first 3 cycles Fluoropyrimidine chemotherapy
Secondary outcome [2] 411522 0
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.
This is a composite endpoint
Timepoint [2] 411522 0
Patient participants to complete 1-2 months after DPYD education and blood collection (to allow time for return of/discussion of results)
Stakeholder questionnaires completed at beginning of site recruitment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not willing to provide consent or blood sample

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
single arm feasibility study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
simple statistical analysis of both discrete and continuous data points

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/01/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
100
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22689 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [2] 22690 0
Gosford Hospital - Gosford
Recruitment hospital [3] 22691 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [4] 22692 0
Muswellbrook Hospital - Muswellbrook
Recruitment postcode(s) [1] 37968 0
2250 - Gosford
Recruitment postcode(s) [2] 37967 0
2290 - Gateshead
Recruitment postcode(s) [3] 37969 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 37970 0
2333 - Muswellbrook

Funding & Sponsors
Funding source category [1] 311768 0
University
Name [1] 311768 0
University of Newcastle
Country [1] 311768 0
Australia
Primary sponsor type
Individual
Name
Clinician- Prof Stephen Ackland
Address
Lake Macquarie Hospital
Gateshead NSW 2290
Country
Australia
Secondary sponsor category [1] 313228 0
University
Name [1] 313228 0
University of Newcastle
Address [1] 313228 0
University Drive
Callaghan NSW 2308
Country [1] 313228 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311209 0
HNELHD HREC
Ethics committee address [1] 311209 0
John Hunter Hospital
Kookaburra Circuit
New Lambton Heights NSW 2305
Ethics committee country [1] 311209 0
Australia
Date submitted for ethics approval [1] 311209 0
01/09/2020
Approval date [1] 311209 0
16/09/2020
Ethics approval number [1] 311209 0
2020/ETH02297
Ethics committee name [2] 311210 0
UoN Research Integrity Unit
Ethics committee address [2] 311210 0
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 311210 0
Australia
Date submitted for ethics approval [2] 311210 0
01/10/2020
Approval date [2] 311210 0
01/10/2020
Ethics approval number [2] 311210 0
H-2020-0351

Summary
Brief 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.
Trial website
https://gicancer.org.au/clinical-trial/genescreen-5-fu/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120338 0
Prof Stephen Ackland
Address 120338 0
Hunter Cancer Centre
Lake Macquarie Specialist Medical Center
6-8 Sydney St, Gateshead NSW 2290
Country 120338 0
Australia
Phone 120338 0
+61 408492868
Fax 120338 0
Email 120338 0
stephen.ackland@newcastle.edu.au
Contact person for public queries
Name 120339 0
Dr Cassandra White
Address 120339 0
Medical Oncology Unit
Maitland Hospital
Metford Road
Metford NSW 2323
Country 120339 0
Australia
Phone 120339 0
+61240871000
Fax 120339 0
Email 120339 0
cassandra.white10@uon.edu.au
Contact person for scientific queries
Name 120340 0
Dr Cassandra White
Address 120340 0
Medical Oncology Unit
Maitland Hospital
Metford Road
Metford NSW 2323
Country 120340 0
Australia
Phone 120340 0
+61240871000
Fax 120340 0
Email 120340 0
cassandra.white10@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD underlying published cohort results, de-identified
When will data be available (start and end dates)?
from time of publication onward
data will only be available as part of de-identified patient cohort data
Available to whom?
Other researchers
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Contact principle investigator or study coordinator via email:
stephen.ackland@newcastle.edu.au
cassandra.white10@uon.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.