Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000638538
Ethics application status
Approved
Date submitted
2/05/2024
Date registered
16/05/2024
Date last updated
16/05/2024
Date data sharing statement initially provided
16/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of finger prick testing for 5-fluorouracil drug level monitoring in cancer patients.
Scientific title
Validation of finger prick testing for 5-fluorouracil drug level monitoring in cancer patients.
Secondary ID [1] 312072 0
None
Universal Trial Number (UTN)
Trial acronym
FFTV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 333697 0
Pancreatic cancer 333698 0
Gastro-oesophageal cancer 333699 0
Condition category
Condition code
Cancer 330375 330375 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 330376 330376 0 0
Pancreatic
Cancer 330377 330377 0 0
Oesophageal (gullet)
Cancer 330378 330378 0 0
Stomach

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We intend to measure the 5-fluorouracil (5FU) blood plasma levels in finger prick samples from 50 patients receiving 5FU and compare them to a peripheral blood sample (the gold standard) with the aim of validating the finger prick test so that it can replace the peripheral blood test and enable better access and participation in the therapeutic drug monitoring of 5FU. Both the peripheral blood test and the finger prick test must occur on Day 2 of the 5FU infusion (when 5FU is at steady state) and both tests are in addition to standard of care treatment, so that only patients enrolled in this study will have a finger prick test. Every participant will return to the hospital (an extra visit when they would otherwise be at home) for these extra tests. After reading the finger prick test instructions, the finger prick test can be completed by the participant if they choose (very similar to blood sugar testing in diabetes), or be the performed by the clinical trial coordinator, trained at least 2 weeks prior to the first enrolment. Patient evaluation of the finger prick instructions & success of self-administration are a secondary endpoint of the study. The Clinical Trial Coordinator will perform the peripheral blood test. The results of these tests will not be used to change clinical management. Any 5FU dose changes are at the discretion of the treating medical oncologist. Once the participant has completed the Day 2 peripheral blood and finger prick test, they have completed the study, however continue in the study and repeat the testing for the next cycle of treatment if they choose.
Intervention code [1] 328514 0
Not applicable
Comparator / control treatment
Gold standard is the peripheral blood test. The comparator is the finger prick test.

Each participant will provide 2 blood samples (a peripheral blood sample and a finger prick sample) which will be compared against each other.

5FU levels from different participants will not be compared. There is no comparator participant group, but each participant's finger prick sample will be compared with their own peripheral blood sample.
Control group
Active

Outcomes
Primary outcome [1] 338141 0
The correlation between 5-fluorouracil plasma drug level measurement in a finger prick test compared to a peripheral blood test.
Timepoint [1] 338141 0
The peripheral blood test & finger prick test need to be measured once (within 10 minutes of each other), anytime between 3 & 40 hours after the start of the infusion. We expect for most patients it will be easier to return to hospital on Day 2 of the infusion (an extra visit) to have a measurement at 18hours after the start of the infusion, however the exact time can be adjusted to suit the patient within this 3-40hour window.
Secondary outcome [1] 434672 0
Evaluation of the Finger Prick Instruction by the participants
Timepoint [1] 434672 0
Within 30 mins after both the peripheral blood test & finger prick test has been completed

Eligibility
Key inclusion criteria
- > 18 years of age
- Able to provide informed consent
- Receiving a 46-hour infusion of 5FU either alone or in combination with other chemotherapies or targeted agents.
- Willing to return to hospital on Day 2 for a consecutive finger prick test and peripheral blood test.
- Any cycle of treatment is permitted
- Patients can participate in the finger prick and peripheral blood testing for more than 1 cycle of treatment.
- Participation in the evaluation of the finger prick instructions is optional
- Participation in providing an extra blood sample for future studies analysing the concentrations of other chemotherapies and targeted agents (already in each patient’s sample as part of their treatment regimen) is optional
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316432 0
Government body
Name [1] 316432 0
Cancer Institute NSW
Country [1] 316432 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 318601 0
None
Name [1] 318601 0
Address [1] 318601 0
Country [1] 318601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315224 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315224 0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Ethics committee country [1] 315224 0
Australia
Date submitted for ethics approval [1] 315224 0
30/01/2024
Approval date [1] 315224 0
27/02/2024
Ethics approval number [1] 315224 0

Summary
Brief summary
This study aims to validate a finger prick test against a peripheral blood test to measure
5-fluorouracil blood levels, so that finger prick testing could be done at home in future.

Who is it for?
You may be eligible for this study if you are an adult male or female receiving a 46-hour infusion of 5FU as part of your treatment for cancer.

Study details
Participants will return to hospital on Day 2 of their infusion to have a consecutive finger prick test and a peripheral blood test. Patients can participate in the finger prick and peripheral blood testing for more than 1 cycle of treatment. The correlation between 5-fluorouracil plasma drug level in a finger prick test compared to a peripheral blood test will be measured, and participants will be asked to complete an evaluation of the finger prick instructions.

It is hoped that findings from this study will validate finger prick testing to replace peripheral blood testing so that testing can occur at home.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134042 0
Dr Alex Flynn
Address 134042 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit New Lambton Heights, NSW, Australia, 2305
Country 134042 0
Australia
Phone 134042 0
+61417454241
Fax 134042 0
Email 134042 0
alex.flynn@newcastle.edu.au
Contact person for public queries
Name 134043 0
Alex Flynn
Address 134043 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit New Lambton Heights, NSW, Australia, 2305
Country 134043 0
Australia
Phone 134043 0
+61417454241
Fax 134043 0
Email 134043 0
alex.flynn@newcastle.edu.au
Contact person for scientific queries
Name 134044 0
Alex Flynn
Address 134044 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit New Lambton Heights, NSW, Australia, 2305
Country 134044 0
Australia
Phone 134044 0
+61417454241
Fax 134044 0
Email 134044 0
alex.flynn@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22322Study protocol  alex.flynn@newcastle.edu.au



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.