None listed
Conditions
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.
Interventions
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.
Sponsors
Eligibility
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
Exclusion criteria
None