About this trial
The aim of the study is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin. The secondary objective is to test the feasibility of home monitoring (microsampling TDM) of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin in oncology patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent;
18 years of age or older;
Using one or more of the following drugs: Cabozantinib, Pazopanib, Sunitinib, Lenvatinib, Imatinib, Abiraterone, Enzalutamide, Nivolumab, Ipilimumab, Pembrolizumab, Atezolizumab, Bevacizumab or Enfortumab vedotin
Disqualifiers
Not able to sample themselves using a finger prick
Trial design
Single group
Treatments tested in this trial
Therapeutic drug monitoring with a dried blood spot and microatainer.
Diagnostic testPatients who use an oral oncolytic will be asked to provide four paired whole blood (WB) samples obtained by venapuncture.
Treatment groups
Trial outcomes
Primary outcomes
Method agreement between whole blood sample (WBS) and bry blood spot (DBS).
Blood concentrations of the oral oncolytic will be obtained 0 to 3 hours after ingestion of the oral oncolytic. Blood concentrations of immune checkpoint inhibitors will be obtained 0 hours after infusion and 15 minutes after end of the infusion. Passing-Bablok analysis will be performed to investigate a linear relationship between WBS and DBS. Bland-Altman analysis will be performed to evaluate method agreement. Method agreement between WBS and DBS was defined as ≥67% of the samples between the range of 0.80 and 1.20 (with or without correction factor following Passing-Bablok analysis)
Sponsors and contacts
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