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临床试验/NCT03865355
NCT03865355已完成不适用

Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults

Novosibirsk State University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Metabolic phenotype of glioma patients

研究概览

简要总结

This is an exploratory, non-interventional and translational clinical study. The aim of this study is to analyze blood and cerebrospinal fluid metabolomic profile in glioma patients.

详细描述

The analysis of metabolic profile in the plasma and CSF could become the new less invasive approach in the establishing diagnosis as well as an important prognostic factor in patients with glioma. The researches will assess the blood and CSF metabolic profile in patients with different types of gliomas as well as in patient without ones. This can help to find new biomarkers for low- and high-grade gliomas correlating with patient outcomes.

Blood and CSF samples will be collected from patients with suspected newly diagnosed low-grade (I-II) or high-grade (III-IV) gliomas as well as from patients who have hospitalized for reconstructive surgery after craniofacial trauma. All samples will be collected before any surgical intervention and at various follow-up time points until progression or death. The results of the study are planned to be translated into the hospital setting as support to other diagnostics procedures and to the differential diagnosis between glioma grades.

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

  • All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy).
  • Patient aged 18 years or older
  • Patients have to be able to give informed consent

排除标准

  • Prior Radiotherapy to the central nervous system
  • Prior Chemotherapy within the last 5 years
  • Any prior central nervous system malignancy
  • Any surgery during last 6 month

结局指标

主要结局

Metabolic phenotype of glioma patients

时间窗: 5 years

Plasma and CSF aminoacids, acylcarnitines, and other metabolites in glioma patients compared to conditionally healthy volunteers by high-performance liquid chromatography coupled with tandem mass spectrometry.

次要结局

  • Progression free survival (PFS)(5 years)
  • Overall survival (OS)(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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