跳至主要内容
临床试验/NCT05775458
NCT05775458招募中不适用

Role of Glutamate-mediate Excitotoxicity in Invasion and Progression Processes of Glioblastoma Multiforme

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 50 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
招募中
入组人数
50
试验地点
1
主要终点
Baseline characterization of Glutamate (Glu) levels in serum

研究概览

简要总结

Gliomas are the most frequent type of primary brain tumors in adults; among them glioblastoma multiforme (GBM) is the most malignant, being associated with the worst prognosis. Glutamate (Glu) is an aminoacid, responsible for essential functions in the Central Nervous System (CNS), acting both as metabolite and neurotransmitter. It is essential for regulating cellular metabolism and developmental synaptogenesis, cellular migration, differentiation and death. Recent scientific evidences have demonstrated alteration in Glu synthesis and signaling being directly involved in GBM growth and invasion

详细描述

Glu and its scavenger's levels are measurable both in serum and in the cerebral-spinal fluid (CSF), thus making them ideal markers for tumor aggressiveness and disease activity as well as a potential target for new therapeutic approaches.

Serum and CSF levels of glutamic oxaloacetic transaminase (GOT1), Glutamate Pyruvate Transaminase (GPT) and glutamate and aspartate levels of a total of 40 patients will be collected.

Molecular biology analyses will be conducted and oncological and imaging data will be collected during follow-up in patients enrolled in the present studies. MRI imaging as well as blood sampling will be performed at definite timepoints (baseline and 3, 6 and 9 months follow-up).

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

  • Adult patients with a brain lesion suspected for GBM, candidate to gross total tumor resection (GTR), followed by radiotherapy and chemotherapy (concomitant and adjuvant).
  • Patient able to provide informed consent.

排除标准

  • Age < 18 years
  • Liver disease
  • Severe anemia (Hb <8mg/dl)
  • Pregnancy

结局指标

主要结局

Baseline characterization of Glutamate (Glu) levels in serum

时间窗: Baseline (before surgery)

Serum Glutamate (μM/L)

Time changes in Glutamate scavengers (Glu-sca) levels in serum

时间窗: At 3, 6, 9 months following surgery

Serum GOT1 (UI/ml), GPT (UI/ml)

Baseline characterization of Glutamate scavengers (Glu-sca) levels in serum

时间窗: Baseline (before surgery)

Serum GOT1 (UI/ml), GPT (UI/ml)

Time changes in Glutamate (Glu) levels in serum

时间窗: At 3, 6, 9 months following surgery

Serum Glutamate (μM/L)

次要结局

  • Characterization of Glutamate (Glu) levels in cerebrospinal fluid (CSF)(Baseline (before surgery))
  • Characterization of Glutamate scavengers (Glu-sca) levels in cerebrospinal fluid (CSF)(Baseline (before surgery))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pietro Mortini, MD, Prof.

Head of department

IRCCS San Raffaele

研究点 (1)

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