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Completed

NCT Number: NCT05598788

Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies

The MISTIK project aims at clinically validating the technique of oral anticancer drugs determination by volumetric absorptive micro-sampling and at comparing the results to measurements performed on venous samples.

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Key information

Conditions

Blood Concentrations of Nine Anti-cancer Drugs : Axitinib, Olaparib, regorafénib, Cabozantinib, Niraparib, Talazoparib, Palbociclib, Abemaciclib, Tucatinib

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Eugène Marquis Unicancer, Rennes, France

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About this study

The International recommendations for the validation of DBS-based methods will be applied (Capiau et al, TDM, 2019) by including 40 patients per molecule of interest. Nine drugs will be monitored : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib.

Two samples will be collected from each patient, one by venous sampling and the second at the same time (approximately) using a capillary blood sample derived from a finger prick.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients treated with one of the 9 drugs concerned by the study : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib
  • person who does not object to their participation in the research

Exclusion criteria

  • Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty

Treatment and study plan

Measurement of drug concentrations

Other

Measurement of anti-cancer drug concentrations using volumetric absorptive micro-sampling (VAMS) and venous blood sample

Other names: Micro-sampling

Primary outcomes

  1. Comparison of venous blood vs VAMS concentrations

    Time frame: 1 day

    Comparison of drug concentrations measured from the venous blood samples with concentrations measured from VAMS

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Development of a Microsampling Approach for Personalized Monitoring of Kinase Inhibitor Targeted Therapies

Acronym: MISTIK

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.