Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- MNPs effect on head and neck cancer patiens
研究概览
简要总结
MICRORAD is a pioneering 48-month translational research project that investigates the potential health and environmental impacts of micro- and nanoplastics (MNPs) released from medical devices when exposed to ionizing radiation. In radiation oncology, thermoplastic masks (TPMs) are standard immobilization tools, particularly for head and neck (HN) cancer patients. Globally, approximately 2.65 million TPMs are used annually in the radiotherapy of HN cancer patients and with an additional 8 to 10 million for other tumor types. TPMs are repeatedly subjected to high-energy X-rays and frequent handling, raising concerns about polymer degradation and the release of MNPs, which may interfere with treatment efficacy or contribute to radiation toxicity.
MICRORAD is the first translational study to explore this phenomenon by integrating clinical oncology, materials science, radiobiology, and data science. The project will analyze radiation-induced changes in TPMs, quantify MNP release, and assess their biological effects through in vitro, in vivo, and clinical studies.
Using advanced detection techniques, the project will characterize MNPs and trace their biodistribution, while a clinical pilot will correlate MNP exposure with treatment outcomes. Data integration, biostatistics, and AI-based modeling will support the translation of findings into clinical guidelines, policy briefs, and public communication.
A multidisciplinary team will collaborate to ensure real-world impact. By bridging oncology and environmental health, MICRORAD aims to establish eco-oncology as a new field, contributing to patient safety and sustainable innovation.
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
- •Any stage head and neck cancer patients
- •Eastern Cooperative Oncology Group performance status 0-2
- •Undergoing radiotherapy with/without cisplatin chemopotentiation
- •Signed informed consent
排除标准
- •Pregnancy or lactation
- •Mental illness
- •Prior or concurrent malignancies
- •Immunotherapy or immunosuppressive therapy
- •Immune diseases
结局指标
主要结局
MNPs effect on head and neck cancer patiens
时间窗: From enrollment to the 6 month FU treatment
To characterize MNPs and trace their biodistribution and to correlate MNP exposure with treatment outcomes
次要结局
未报告次要终点
研究者
Marija Zivkovic Radojevic
Assistant Professor
University of Kragujevac
