Clinical trial · Interventional
Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients
Microsampling to Facilitate Drug Monitoring of Oncolytics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Monitoring | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapeutic drug monitoring with a dried blood spot and microatainer. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microsampling arm
- description
- Patients who use an oral oncolytic will be asked to provide twelve microsamples obtained by finger prick: * 6 dried blood spots (DBS) * 6 volumetric absorptive microsampling (VAMS))
- interventionNames
- Diagnostic Test: Therapeutic drug monitoring with a dried blood spot and microatainer.
Primary outcomes (1)
- measure
- Method agreement between whole blood sample (WBS) and bry blood spot (DBS).
- timeFrame
- All samples will be collected within 3 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Not able to sample themselves using a finger prick
References
Publications (0)
Data not yet available