Sibul Filip, Burkhardt Therese, Kachhadia Alpeshkumar, Pilz Fabian, Scherer Gerhard, Scherer Max, Pluym Nikola
Analytisch-Biologisches Forschungslabor GmbH, Semmelweisstr. 5, 82152 Planegg, Germany.
Contemp Clin Trials Commun. 2021 Jun 2;22:100794. doi: 10.1016/j.conctc.2021.100794. eCollection 2021 Jun.
Assessing biomarker profiles in various body fluids is of large value to discern between the sole use of nicotine products. In particular, the assessment of the product compliance is required for long-term clinical studies. The objective of this study was the identification of biomarkers and biomarker patterns in body fluids, to distinguish between combustibles, heated tobacco products, electronic cigarettes, oral tobacco and oral/dermal nicotine products used for nicotine replacement therapy (NRT), as well as a control group of non-users.
A controlled, single-center study was conducted with 60 healthy subjects, divided into 6 groups (5 nicotine product user groups and one non-user group) based on their sole use of the products of choice. The subjects were confined for 76 h, during which, free and uncontrolled use of the products was provided. Sample collections were performed according to the study time schedule provided in Table 2. The primary outcome will be validated through analysis of the collected biospecimens (urine, blood, saliva, exhaled breath and exhaled breath condensate) by means of untargeted omics approaches (i.e. exposomics, breathomics and adductomics). Secondary outcome will include established biomarker quantification methods to allow for the identification of typical biomarker patterns. Statistical analysis tools will be used to specifically discriminate different product use categories.
RESULTS/CONCLUSIONS: The clinical trial was successfully completed in May 2020, resulting in sample management and preparations for the quantitative and qualitative analyses. This work will serve as a solid basis to discern between biomarker profiles of different nicotine product user groups. The knowledge collected during this research will be required to develop prototype diagnostic tools that can reliably assess the differences and evaluate possible health risks of various nicotine products.
评估各种体液中的生物标志物谱对于区分仅使用尼古丁产品具有重要价值。特别是，长期临床研究需要评估产品依从性。本研究的目的是识别体液中的生物标志物和生物标志物模式，以区分可燃烟草制品、加热烟草制品、电子烟、口用烟草以及用于尼古丁替代疗法（NRT）的口用/皮肤用尼古丁产品，以及一个非使用者对照组。
对60名健康受试者进行了一项对照单中心研究，根据他们对所选产品的单一使用情况分为6组（5个尼古丁产品使用者组和1个非使用者组）。受试者被限制76小时，在此期间，可自由且无限制地使用产品。根据表2中提供的研究时间表进行样本采集。主要结果将通过非靶向组学方法（即暴露组学、呼吸组学和加合物组学）对收集的生物标本（尿液、血液、唾液、呼出气体和呼出气体冷凝物）进行分析来验证。次要结果将包括建立生物标志物定量方法，以识别典型的生物标志物模式。将使用统计分析工具来专门区分不同的产品使用类别。
结果/结论：该临床试验于2020年5月成功完成，完成了样本管理以及定量和定性分析的准备工作。这项工作将为区分不同尼古丁产品使用者组的生物标志物谱奠定坚实基础。开展本研究过程中收集到的知识将用于开发能够可靠评估差异并评估各种尼古丁产品潜在健康风险的原型诊断工具。
