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临床试验/NCT05556382
NCT05556382招募中不适用

Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity (GEHIRN): Preclinical Observational Study on Ex-vivo Surgical Specimens

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Determination of distribution of number of γH2AX foci in each irradiated specimen (Nfoci) for each radiation dose level

研究概览

简要总结

This is an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular the investigators will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.

详细描述

Standard of care for newly diagnosed glioblastoma (GBM) patients consists of surgical resection followed by radiotherapy with concurrent and adjuvant Temozolomide chemotherapy. Despite these treatments, the prognosis remains poor. Nevertheless, preliminary data on GBM patients show variable outcomes related to a different treatment response, that could be related to the GBM intrinsic heterogeneity, but also to a different patient sensitivity to radiation therapy.

The assessment of this individual radio-sensitivity may provide valuable data to define more tailored treatment schedules, that could potentially be more effective.

Published studies on small cohort of patients show that a possible system to investigate the tumor radiation sensitivity, is to monitor the cellular DNA damage after tissue irradiation, that correlates with the survival fraction of in vitro tumor cells; the DNA damage could be identified through the quantification of Phosphorylated histone H2AX nuclear foci that correlate with the unrepaired DNA double strand breaks (DSBs).

Based on this background, The investigators designed an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular they will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.

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

  • Patients aged >18 years
  • Patients eligible for diagnostic or therapeutic surgical procedure
  • Written informed consent
  • Histopathologically confirmed newly diagnosed glioblastoma according to WHO 2021
  • Availability of fresh tissue samples

排除标准

  • Other extra-cranial cancer
  • Non GBM glioma
  • Previous brain radiation therapy

结局指标

主要结局

Determination of distribution of number of γH2AX foci in each irradiated specimen (Nfoci) for each radiation dose level

时间窗: 1 month

Number of foci per irradiated sample (Nfoci) for each dose level expressed as \[(number of observed γH2AX foci per selected dose level)-(number of observed γH2AX foci in control unirradiated sample)\].

次要结局

  • correlation between n° of γH2AX foci and dose levels(1 month)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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