Skip to content

Microsampling for therapeutic drug monitoring of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax

Microsampling for therapeutic drug monitoring of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax - Microsampling Oral Oncolytics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57005
Enrollment
150
Registered
2024-05-02
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leukaemia

Interventions

Patients will be asked to provide twelve microsampling samples obtained by finger prick (eight dried microsampling spots and four wet blood samples in microtainer EDTA) and four plasma samples obtai

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Willing and able to provide informed consent; • 18 years of age or older; • Using one of the following drugs: o Imatinib o Dasatinib o Nilotinib o Gilteritinib o Midostaurin o Venetoclax

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Not able to sample themselves using a finger prick.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the method agreement between plasma and microsampling (DBS/VAMS). The secondary endpoints are the success rate of microsampling and the difference in SUS score between HemaXis DB 10 and Mitra Clamshell.

Secondary

MeasureTime frame
• Success rate of microsampling: calculated by the percentage of DBS/VAMS spots that was accepted for analysis by the laboratory technician. Reasons for disapproval will be described by the laboratory technician . • SUS score: calculated by converting the questionnaire into a 0 to 100 scale score. In the SUS scale, *strongly disagree* correlates with 1 point, *disagree* with 2 points, *neutral* with 3 points, *agree* with 4 points and *strongly agree* with five points. The SUS score equals to (X + Y) x 2.5. X is the sum of the points for all odd-numbered questions minus 5. Y is 25 minus the sum of all even-numbered questions.

Countries

Netherlands

Contacts

Public ContactAD Levens

Leids Universitair Medisch Centrum

a.d.levens@lumc.nl0715298531

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026