None listed
Conditions
Brief summary
The purpose of this study is to investigate whether it is possible for blood samples to be used to monitor whether the correct dose of cancer medicines are being provided to patients. Who is it for? You may be eligible for this study if you are an adult who is receiving Fluorouracil (5-FU) or Capecitabine for the treatment of cancer. Study details All participants in this study will need to provide two blood samples and one dried blood spot sample at two visits with a pathologist. Any results from these samples will then be provided to your oncologist. It is hoped that this research will help determine if it is possible to monitor the dose of medication needed per individual using blood samples.
Interventions
Patients prescribed 5-FU/Capecitabine as part of their standard of care treatment will provide an additional 2 blood samples and a single dried blood spot for therapeutic drug monitoring.
Samples will be collected by either doctor, research nurse or pathology collector. The first sample is collected at the patient's screening visit with other routine blood samples. The second sample will be collected additionally during the patient's treatment and will require 10 minutes for collection.
Leve
Patients prescribed 5-FU/Capecitabine as part of their standard of care treatment will provide an additional 2 blood samples and a single dried blood spot for therapeutic drug monitoring. Samples will be collected by either doctor, research nurse or pathology collector. The first sample is collected at the patient's screening visit with other routine blood samples. The second sample will be collected additionally during the patient's treatment and will require 10 minutes for collection. Levels of drug will be provided back to clinician and dose of 5-FU/Capecitabine may change based on individual clinicians clinical judgement. The level of drug in blood sample will be correlated with level of drug in dried blood spot for feasibility of using dried blood spot and/or whole blood samples for ongoing therapeutic drug monitoring of 5-FU/Capecitabine. The change (is applicable) and outcome will be collected.
Sponsors
University of Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any patient scheduled for infusional 5-FU greater than 24 hours, or capecitabine treatment, along or in combination. Available and willing to have blood tests inthe period after initiation of treatment Can provide signed, written informed consent.
Exclusion criteria
None
Outcome results
None listed