Decentralized Therapeutic Drug Monitoring of Taxanes and ALK Inhibitors in NSCLC: A Real-World Feasibility Study Using the True Dose Capillary Self-Sampling System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration
研究概览
简要总结
This study will evaluate whether people with non-small cell lung cancer (NSCLC) can collect small blood samples themselves using a finger-prick sampling kit. Participants will be receiving standard treatment with docetaxel, paclitaxel, alectinib, or lorlatinib.
The blood samples will be used to measure the amount of cancer medicine in the blood. Most samples will be collected by participants at home and returned to a laboratory for analysis. The study will assess how easy the sampling method is to use, whether the collected samples are suitable for laboratory analysis, and how patients and healthcare professionals experience this way of collecting blood samples.
The study will also explore whether measured drug levels are related to side effects, dose changes, treatment delays, or other clinical outcomes. The drug-level results collected in this study will be used for research purposes and will not be used to change participants' cancer treatment.
About 80 participants will take part in the study and will be followed for approximately 3 months.
The microsampling device is CE-marked and used within its approved use exclusively for research and feasibility evaluation. Study results do not influence ongoing clinical treatment decisions.
This study is being conducted as part of Project-COMFORT, a European multi-country initiative aiming to evaluate the feasibility and implementation of PCmS across various populations and healthcare systems.
详细描述
This prospective, non-interventional feasibility and implementation study evaluates decentralized therapeutic drug monitoring (TDM) using capillary self-sampling in adults with non-small cell lung cancer (NSCLC) receiving standard-of-care treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. The study focuses on the feasibility, usability, and implementation of patient-centric microsampling in routine oncology care.
Participants will be trained to collect a small capillary whole-blood sample using a finger prick. Samples will be collected mainly at home and returned by mail for laboratory analysis. Sampling schedules are adapted to the treatment received. For participants receiving taxanes, capillary samples are collected at defined time points after infusion. For participants receiving ALK inhibitors, samples are collected at home in relation to the scheduled oral dose.
The primary focus of the study is whether participants can successfully perform capillary self-sampling and whether the returned samples are suitable for laboratory analysis. Participant experience, usability, need for assistance, and practical aspects of integrating home-based sampling into oncology care will also be evaluated. Qualitative interviews or focus groups with patients and healthcare professionals will explore barriers and facilitators to implementation and the potential impact of decentralized sampling on clinical workflows.
Drug concentrations will be measured for research purposes. Exploratory analyses will examine associations between drug exposure and clinical measures such as treatment-related toxicity, dose modifications or delays, hospital visits, and clinical response when available. In participants with both capillary and venous samples, the relationship between concentrations measured using the two sampling methods may also be evaluated.
Participants will continue to receive their prescribed cancer treatment according to standard clinical practice. The study does not introduce an investigational medicinal product, randomize participants, or require treatment changes based on study measurements. Drug concentration results obtained through capillary self-sampling will not be used to guide treatment decisions during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Receiving ongoing standard-of-care treatment with docetaxel, paclitaxel, alectinib, or lorlatinib.
- •Able to understand Swedish or English and provide written informed consent. Willing and able to comply with study-required procedures, including blood sample collection.
- •Able to perform capillary self-sampling at home, with or without support from a caregiver or healthcare professional.
- •Access to a stable home or remote environment suitable for sample collection and, where applicable, home nurse visits.
- •Able to participate in the required sample collection and shipping procedures, independently or with support from a family member or caregiver.
排除标准
- •Concurrent participation in another interventional study that may affect pharmacokinetics.
- •Severe coagulopathy or another contraindication to capillary blood sampling. Known hypersensitivity to a previously used adhesion system used for sample collection.
- •Any condition that, in the investigator's judgment, would make study participation unsafe or infeasible, including skin infection or another skin condition at the intended sample collection site.
研究组 & 干预措施
Taxane Cohort
Participants with non-small cell lung cancer receiving standard-of-care treatment with docetaxel or paclitaxel will use the True Dose® capillary self-sampling system for collection of blood samples for therapeutic drug monitoring research. Participants will perform capillary sampling at predefined time points following taxane administration. Study drug concentration results will not be used to guide treatment decisions.
干预措施: True Dose® Capillary Self-Sampling System (Device)
ALK Inhibitor Cohort
Participants with non-small cell lung cancer receiving standard-of-care treatment with alectinib or lorlatinib will use the True Dose® capillary self-sampling system for collection of blood samples for therapeutic drug monitoring research. Capillary samples will be collected at home in relation to the participant's regular oral treatment. Study drug concentration results will not be used to guide treatment decisions.
干预措施: True Dose® Capillary Self-Sampling System (Device)
结局指标
主要结局
Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration
时间窗: From first scheduled home sampling until completion of the sampling period, approximately 1 month.
Proportion of participants who successfully complete at least one scheduled home capillary self-sampling procedure resulting in a laboratory-approved sample and a reportable drug concentration. Success is defined as completion of all of the following: (1) participant performs the capillary self-collection within the predefined sampling window; (2) the sample is received by the laboratory; (3) the sample meets predefined laboratory suitability criteria, including sufficient sample volume and acceptable sample integrity; and (4) the relevant drug concentration can be successfully quantified using the validated analytical method. The outcome will be reported as the number and percentage of participants meeting all criteria.
次要结局
- Usability and Acceptability of Capillary Self-Sampling(Through study completion, approximately 3 months)
- Need for Assistance With Capillary Self-Sampling(Through study completion, approximately 3 months)
- Laboratory Sample Suitability(Through study completion, approximately 3 months)
- Barriers and Facilitators to Implementation of Capillary Self-Sampling(Through study completion, approximately 3 months)
研究者
Elham Hedayati
MD, PhD
Karolinska Institutet