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临床试验/NCT05786144
NCT05786144已完成不适用

Vestibular Schwannoma Stem Cell Organoids

Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Feasibility

研究概览

简要总结

In standard of care regularly planned surgery, tissue will be obtained from patients who are suspicious for having vestibular Schwannoma (on MRI). The tissue that remains after the pathologist gathered sufficient for analysis, the remaining tissue is used for creating tumour stem cell organoids.

详细描述

This project constitutes scientific research since the presence of tumor stem cells has not been shown in schwannoma before. Secondly the organoid model has not yet been described for VSs. The correlation between effect in schwannoma organoids and in patients has to be evaluated but can proof to be very valuable since it has been shown in a number of tumors. The tumor tissue will be acquired during regularly planned surgery. The tissue that is used is what is left after sufficient material has been sent to the pathologist to make the diagnosis. So the tissue that is used is removed routinely during surgery, but instead of banking it at the pathology department, it is used for the research project. Blood samples that can be used to compare normal DNA to tumor cells DNA will be acquired from central lines that are routinely placed during these procedures, so no additional interventions will be done in acquiring the tissue and blood for this study.

研究设计

研究类型
Observational
观察模型
Other
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

  • MRI with suspicion for vestibular schwannoma
  • Indication for surgery in the skull base committee
  • 18 years or older

排除标准

  • Refusal to participate
  • Younger than 18 years
  • Incapacitated

结局指标

主要结局

Feasibility

时间窗: 10 years

Feasibility to create organoids from schwannoma tumour tissue and make a "living" biobank of these tissues in the laboratory to study the resistance mechanisms towards treatments.

次要结局

  • Phenotype(10 years)
  • Epigenetic(10 years)
  • Genetic(10 years)
  • Proteomic(10 years)
  • Transcriptomic(10 years)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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