TailorDose Lung: Decentralized TDM of Taxanes and ALK Inhibitors Using Capillary Self-Sampling (TD-Lung)
Decentralized Therapeutic Drug Monitoring of Taxanes and ALK Inhibitors in NSCLC: A Real-World Feasibility Study Using the True Dose Capillary Self-Sampling System
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Elin Backman Stålnacke, Speciliased Nurse in Oncology
- Telefonní číslo: +46 8 123 711 85
- E-mail: elin.backman-stalnacke@regionstockholm.se
Studijní záloha kontaktů
- Jméno: Elham Hedayati, MD PhD
- Telefonní číslo: +46 709261035
- E-mail: elham.hedayati@ki.se
Studijní místa
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Stockholm, Švédsko, 17166
- Institution of Oncology-Pathology
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Kontakt:
- Elham Hedayati, MD phD
- Telefonní číslo: +46709261035
- E-mail: elham.hedayati@ki.se
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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The True Dose® capillary self-sampling system is a patient-centric microsampling system that enables collection of approximately 50 µL of capillary whole blood using a finger prick.
Participants are trained to perform capillary blood collection, primarily at home, and samples are returned by mail for laboratory analysis of drug concentrations.
The study evaluates the feasibility, usability, and sample suitability of decentralized capillary self-sampling for therapeutic drug monitoring.
Results from study-specific drug concentration measurements will be used for research purposes and will not be used to guide participants' cancer treatment.
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Experimentální: 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.
|
The True Dose® capillary self-sampling system is a patient-centric microsampling system that enables collection of approximately 50 µL of capillary whole blood using a finger prick.
Participants are trained to perform capillary blood collection, primarily at home, and samples are returned by mail for laboratory analysis of drug concentrations.
The study evaluates the feasibility, usability, and sample suitability of decentralized capillary self-sampling for therapeutic drug monitoring.
Results from study-specific drug concentration measurements will be used for research purposes and will not be used to guide participants' cancer treatment.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration
Časové okno: From first scheduled home sampling until completion of the sampling period, approximately 1 month.
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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.
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From first scheduled home sampling until completion of the sampling period, approximately 1 month.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Usability and Acceptability of Capillary Self-Sampling
Časové okno: Through study completion, approximately 3 months
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Participant-rated ease of performing capillary self-sampling, assessed using the study-specific patient questionnaire. Participants rate the statement "It was easy to take the blood sample myself" on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater perceived ease of use. Results will be reported as the distribution of responses and/or median and interquartile range. Participant acceptability of decentralized capillary self-sampling, assessed using the study-specific patient questionnaire on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater acceptability. The predefined acceptability item will assess willingness to use home capillary self-sampling as part of future cancer care. |
Through study completion, approximately 3 months
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Need for Assistance With Capillary Self-Sampling
Časové okno: Through study completion, approximately 3 months
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Proportion of participants who require assistance or report difficulty when using the capillary self-sampling system.
This outcome will assess whether the training materials and instructions are sufficient to support participants in performing the sampling procedure.
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Through study completion, approximately 3 months
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Laboratory Sample Suitability
Časové okno: Through study completion, approximately 3 months
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Number and proportion of returned capillary blood samples meeting all predefined laboratory suitability criteria for drug concentration analysis.
A sample will be classified as suitable when sufficient sample volume is available, sample integrity is acceptable, and the sample can proceed to quantitative analysis according to the predefined laboratory procedures.
The denominator will be all capillary samples received by the laboratory.
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Through study completion, approximately 3 months
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Barriers and Facilitators to Implementation of Capillary Self-Sampling
Časové okno: Through study completion, approximately 3 months
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Barriers and facilitators to implementation of patient-centric microsampling will be explored through semi-structured focus groups and/or interviews with patients and healthcare professionals.
The evaluation will address uptake and adherence, trust, usability and acceptability, training needs, effects on clinical workflow and communication, and patient autonomy.
Interviews will be audio-recorded, transcribed verbatim, and analyzed using qualitative content analysis.
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Through study completion, approximately 3 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Capillary Blood Concentration of Docetaxel
Časové okno: At predefined pharmacokinetic sampling time points during docetaxel treatment, through study completion, approximately 3 months.
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Docetaxel concentration measured in capillary blood at predefined sampling time points using the validated quantitative analytical method.
Concentrations will be reported in ng/mL.
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At predefined pharmacokinetic sampling time points during docetaxel treatment, through study completion, approximately 3 months.
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Capillary Blood Concentration of Paclitaxel
Časové okno: At predefined pharmacokinetic sampling time points during paclitaxel treatment, through study completion, approximately 3 months.
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Paclitaxel concentration measured in capillary blood at predefined sampling time points using the validated quantitative analytical method.
Concentrations will be reported in ng/mL.
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At predefined pharmacokinetic sampling time points during paclitaxel treatment, through study completion, approximately 3 months.
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Capillary Blood Trough Concentration (Cmin) of Alectinib
Časové okno: At predefined steady-state sampling during alectinib treatment, through study completion, approximately 3 months.
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lectinib trough concentration (Cmin) measured in capillary blood at the predefined steady-state sampling time point.
Concentrations will be reported in ng/mL.
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At predefined steady-state sampling during alectinib treatment, through study completion, approximately 3 months.
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Capillary Blood Trough Concentration (Cmin) of Lorlatinib
Časové okno: At predefined steady-state sampling during lorlatinib treatment, through study completion, approximately 3 months.
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Lorlatinib trough concentration (Cmin) measured in capillary blood at the predefined steady-state sampling time point.
Concentrations will be reported in ng/mL.
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At predefined steady-state sampling during lorlatinib treatment, through study completion, approximately 3 months.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Simon Ekman, Professor, MD, PhD, Karolinska Institutet
Publikace a užitečné odkazy
Obecné publikace
- Groenland SL, Geel DR, Janssen JM, de Vries N, Rosing H, Beijnen JH, Burgers JA, Smit EF, Huitema ADR, Steeghs N. Exposure-Response Analyses of Anaplastic Lymphoma Kinase Inhibitors Crizotinib and Alectinib in Non-Small Cell Lung Cancer Patients. Clin Pharmacol Ther. 2021 Feb;109(2):394-402. doi: 10.1002/cpt.1989. Epub 2020 Aug 19.
- Maass KF, Barfield MD, Ito M, James CA, Kavetska O, Kozinn M, Kumar P, Lepak M, Leuthold LA, Li W, Mikhailov D, Patel S, Perez NL, Jackson Rudd D, Vakkalagadda B, Williams TM, Zha J, Zhang X, Anderson MD. Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality. Clin Transl Sci. 2022 Dec;15(12):2785-2795. doi: 10.1111/cts.13411. Epub 2022 Oct 8.
- Komninos N, De Chiara S, Checa A, Wiklander O, Rydberg P, Hedayati E. Development and evaluation of a novel capillary blood collection method for decentralized therapeutic drug monitoring using the True Dose kit. Sci Rep. 2025 Sep 29;15(1):33331. doi: 10.1038/s41598-025-20951-5.
- Crafoord MT, Hedayati E, Johnsson A. Capillary Blood Self-Sampling for Therapeutic Drug Monitoring: A Mixed-Methods Usability Study of the True Dose(R) Kit. Biomed Res Int. 2025 Jul 9;2025:9973081. doi: 10.1155/bmri/9973081. eCollection 2025.
- Mc Laughlin AM, Schmulenson E, Teplytska O, Zimmermann S, Opitz P, Groenland SL, Huitema ADR, Steeghs N, Muller L, Fuxius S, Illerhaus G, Joerger M, Mayer F, Fuhr U, Holdenrieder S, Hempel G, Scherf-Clavel O, Jaehde U, Kloft C, For The On-Target Study Consortium. Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol. Cancers (Basel). 2021 Dec 14;13(24):6281. doi: 10.3390/cancers13246281.
- Kicken MP, Deenen MJ, van der Wekken AJ, van den Borne BEEM, van den Heuvel MM, Ter Heine R. Opportunities for Precision Dosing of Cytotoxic Drugs in Non-Small Cell Lung Cancer: Bridging the Gap in Precision Medicine. Clin Pharmacokinet. 2025 Apr;64(4):511-531. doi: 10.1007/s40262-025-01492-6. Epub 2025 Mar 5.
- Beumer JH. Without therapeutic drug monitoring, there is no personalized cancer care. Clin Pharmacol Ther. 2013 Mar;93(3):228-30. doi: 10.1038/clpt.2012.243. No abstract available.
- Hertz DL, Joerger M, Bang YJ, Mathijssen RH, Zhou C, Zhang L, Gandara D, Stahl M, Monk BJ, Jaehde U, Beumer JH. Paclitaxel therapeutic drug monitoring - International association of therapeutic drug monitoring and clinical toxicology recommendations. Eur J Cancer. 2024 May;202:114024. doi: 10.1016/j.ejca.2024.114024. Epub 2024 Mar 19.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Klíčová slova
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