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临床试验/NCT07690631
NCT07690631尚未招募不适用

Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:

University of Kragujevac0 个研究点目标入组 500 人开始时间: 2026年9月1日最近更新:
适应症

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

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

发起方
University of Kragujevac
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marija Zivkovic Radojevic

Assistant Professor

University of Kragujevac

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