Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients

NCT06545292 | Recruiting

• 1 other identifier: 86496
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• 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)

  All samples will be collected within 3 months

Study Arms (1)

Microsampling arm

EXPERIMENTAL

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))

Diagnostic Test: Therapeutic drug monitoring with a dried blood spot and microatainer.

Interventions

Therapeutic drug monitoring with a dried blood spot and microatainer. DIAGNOSTIC_TEST

Patients who use an oral oncolytic will be asked to provide four paired whole blood (WB) samples obtained by venapuncture.

Microsampling arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent;
• 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

You may not qualify if:

• Not able to sample themselves using a finger prick

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Interventions

Drug Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Tom Van Der Hulle, MD PhD

CONTACT

0031715263464; t.van_der_hulle@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Model Details: A single center prospective clinical validation study.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 9, 2024
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

NL (1)