Development of a Microsampling Approach for Personalized Monitoring of Kinase Inhibitor Targeted Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Comparison of venous blood vs VAMS concentrations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty
结局指标
主要结局
Comparison of venous blood vs VAMS concentrations
时间窗: 1 day
Comparison of drug concentrations measured from the venous blood samples with concentrations measured from VAMS
次要结局
未报告次要终点