LBPO.CL02 · 临床研究 · Late-Breaking
通过临床可用的可穿戴细胞因子生物传感器对转移性乳腺癌进行多组学、HER2导向的监测
Multi-omic, HER2-directed monitoring in metastatic breast cancer through a clinic-ready wearable cytokine biosensor
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
背景：肿瘤学中的免疫与炎症监测目前仍受限于间歇性的血液采样，这种方式会错过疾病激活、治疗相关毒性以及新出现耐药的早期信号。我们的可穿戴平台在炎症和免疫失调环境中产生的初步数据表明，基于汗液的细胞因子追踪能够以高时间分辨率无创地捕捉动态免疫变化。基于这些基础性成果，本项目的总体目标是将该技术转化为一种针对HR+/HER2−和HER2+转移性乳腺癌（MBC）的多组学、HER2导向的监测策略。
方法：为支持在转移性乳腺癌中进行纵向、微创的免疫监测，我们采用了一种专为诊室外实时评估而设计的可穿戴平台。在炎症和高风险队列中开展的初步台式和体表研究，借助AI辅助的智能手机分析，确立了该平台的分析有效性以及与参考免疫测定法的一致性。该技术是一种柔性、贴附于皮肤的微流控汗液贴片，可实现对TNF-alpha、IL-6、IL-1beta和C反应蛋白的多重比色检测。在一项以HER2为重点的扩展研究中，该平台将与纵向的肿瘤及血液基因组学相结合，以扩展生物标志物组合，并开发将汗液细胞因子动态变化与HR+/HER2−和HER2+转移性乳腺癌治疗反应及耐药相关联的AI模型。
结果：在初步的炎症性疾病阶段，我们的设备展现出用于高频免疫监测的临床可用性，能够在日常活动中可靠地采集汗液，并与标准免疫测定法高度一致。从工程角度来看，该设备维持了无需泵驱动、由毛细作用驱动的流动，并产生了稳健的、浓度依赖性的细胞因子信号，具有低pg/mL级别的灵敏度、宽广的线性范围以及低设备间差异。这些数据直接为HER2-MBC项目设计提供了依据，包括采样时间表、目标范围以及耐药预警的分析阈值。
结论：该可穿戴设备在炎症性疾病中提供了类似首次人体试验的、无创的定量细胞因子监测数据，为在MBC中开展HER2导向的多组学精准监测策略提供了关键的初步证据。通过将一个经过验证的可穿戴生物传感器与HR+/HER2−和HER2+ MBC中的深度分子分析相结合，即将开展的项目旨在提供实时的、基于汗液的生物标志物，以预判耐药、指导适应性治疗，并减少对侵入性、低频的组织和血液采样的依赖。
查看英文原文 English abstract
Background: Immune and inflammatory monitoring in oncology remains limited by intermittent blood sampling that misses early signals of disease activation, treatment-related toxicities, and emerging resistance. Preliminary data from our wearable platform, generated in inflammatory and immune-dysregulation settings, demonstrate that sweat-based cytokine tracking can noninvasively capture dynamic immune changes with high temporal resolution. Building on these foundational results, the overarching goal of our project is to translate this technology into a multi-omic, HER2-directed monitoring strategy for HR+/HER2− and HER2+ metastatic breast cancer (MBC).
Methods: To support longitudinal, minimally invasive immune monitoring in metastatic breast cancer, we use a wearable platform designed for real-time assessment outside the clinic. Preliminary benchtop and on-body studies in inflammatory and high-risk cohorts established analytical validity and concordance with reference immunoassays using AI-assisted smartphone analysis. The technology is a flexible, skin-mounted microfluidic sweat patch enabling multiplex colorimetric detection of TNF-alpha, IL-6, IL-1beta, and C-reactive protein. In a HER2-focused extension, this platform will be integrated with longitudinal tumor and blood genomics to expand the biomarker panel and develop AI models linking sweat cytokine dynamics to therapeutic response and resistance in HR+/HER2− and HER2+ metastatic breast cancer.
Results: In the preliminary inflammatory disease phase, our device demonstrated clinical readiness for high-frequency immune surveillance, with reliable sweat collection during routine activity, and strong concordance with standard immunoassays. From an engineering standpoint, the device sustained pump-free, capillary-driven flow and generated robust, concentration-dependent cytokine signals with low pg/mL sensitivity, broad linear ranges, and low device-to-device variability. These data directly inform the HER2-MBC project design, including sampling schedules, target ranges, and analytical thresholds for resistance alerts.
Conclusions: This wearable device provides first-in-human-like, noninvasive, quantitative cytokine monitoring data in inflammatory disease that serve as critical preliminary evidence for a HER2-directed, multi-omic precision monitoring strategy in MBC. By coupling a validated wearable biosensor with deep molecular profiling in HR+/HER2− and HER2+ MBC, the forthcoming project aims to deliver real-time, sweat-based biomarkers that anticipate resistance, guide adaptive therapy, and reduce reliance on invasive, low-frequency tissue and blood sampling.
利益披露 Disclosure
R. Bayat Mokhtari, None..
E. Haghani, None..
F. Rahimi, None..
S. Rozenblat, None..
S. Arshadi, None..
P. Torabian, None..
M. Falahat Chian, None..
T. Sachlos, None..
N. Baluch, None..
R. Salahandish, None.