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临床试验/NCT07211841
NCT07211841尚未招募不适用

Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Correlations between initial spectroscopic parameters, basic clinical and biological informations

研究概览

简要总结

Glioblastoma multiforme (GBM) is the most common primary brain tumor, and it is well-known to be associated with a poor prognosis. MRI is the key medical technique for the diagnosis and the follow-up of GBM. By allowing for MRS studies, MRI permits a non-invasive characterization of the TME of GBM, including their metabolic characterization. The investigators propose to address the link between the MRS profile of GBM and basic clinical and biological parameters, with the aim of : i) identifying correlations between these parameters, ii) attempting to integrate clinical, biological and spectroscopic profiles of GBM. The investigators plan to recruit 30 newly diagnosed GBM patients for which surgery / radiochemotherapy will be proposed in the Medical oncology unit of Amiens University Hospital. Following inclusion of patients with probable GBM, MRS study will be performed during the first (pre-therapeutic) MRI examination. Basic clinical and biological parameters of the blood (CRP, complete blood count, fibrinogen, lactate and choline) will be assessed. A metabolomic study will also be performed on the plasma of GBM patients before any therapeutics. A second biological, post-therapeutic assesment (one month after surgery/radiochemotherapy) will allow the same analyses (basic biological parameters + plasma metabolomics), in order to examine the stability of the blood parameters.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •Patients consecutively identified in the multidisciplinary consultation meeting of neurooncology with a new diagnosis of GBM / a probable diagnosis of GBM. - Patients that have not started radiochemotherapy ;
  • •Adult > 18 yrs
  • •socially-insured,
  • •having given consent.

排除标准

  • •minor patients,
  • •pregnant/lactating women,
  • •patients under guardianship,
  • •curatorship,
  • •protection of justice or deprived of liberty

结局指标

主要结局

Correlations between initial spectroscopic parameters, basic clinical and biological informations

时间窗: 12 months

correlations between initial spectroscopic parameters of the tumor, basic clinical information and biological assessment of the blood in a cohort of newly-diagnosed GBM Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).

次要结局

  • Variation from baseline of blood parameters(at 1 month)
  • Progression-free survival(at 12 months)
  • Overall survival(at 12 months)
  • Correlation of biological and metabolomic data with progression-free survival(at 12 months)
  • Correlation of biological and metabolomic data with overall survival(at 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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