Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05775458

Glutamate Excitotoxicity and Its Role in Glioblastoma Biology

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Brain Tumor, Primary Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location status: Recruiting

Location contact

Laura Sincinelli

CONTACT

[email protected]

003926435568

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Blood, CSF and tumor samples

Diagnostic Test

Blood, CSF and brain tissue sampling of Glu and Glu regulatory proteins.

Primary outcomes

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

    Time frame: Baseline (before surgery)

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

  2. Baseline characterization of Glutamate (Glu) levels in serum

    Time frame: Baseline (before surgery)

    Serum Glutamate (μM/L)

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

    Time frame: At 3, 6, 9 months following surgery

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

  4. Time changes in Glutamate (Glu) levels in serum

    Time frame: At 3, 6, 9 months following surgery

    Serum Glutamate (μM/L)

Secondary outcomes

  1. Characterization of Glutamate scavengers (Glu-sca) levels in cerebrospinal fluid (CSF)

    Time frame: Baseline (before surgery)

    CSF levels GOT1 (UI/ml), GPT (UI/ml)

  2. Characterization of Glutamate (Glu) levels in cerebrospinal fluid (CSF)

    Time frame: Baseline (before surgery)

    CSF levels Glutamate (μM/L)

Other outcomes

  1. Association between Glutamate metabolism and Glioblastoma molecular signature

    Time frame: Baseline levels of markers

    Association between Glu and Glu-scavengers' levels and molecular patterns of Glioblastoma as described by 2021 WHO classification

Study contacts

Contact information is provided by the study sponsor or research team.

Sincinelli Laura

CONTACT

[email protected]

0226436658 ext. 0039

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Mar 20, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.