Glutamate Excitotoxicity and Its Role in Glioblastoma Biology
ConditionBrain Tumor, Primary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age < 18 years
Liver disease
Severe anemia (Hb <8mg/dl)
Pregnancy
Trial population
Adult patients with a brain lesion suspected for GBM, candidate to gross total tumor resection (GTR), followed by radiotherapy and chemotherapy (concomitant and adjuvant).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood, CSF and tumor samples
Diagnostic testBlood, CSF and brain tissue sampling of Glu and Glu regulatory proteins.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Adult neurosurgical patients1 intervention
Trial outcomes
Primary outcomes
1
Baseline characterization of Glutamate scavengers (Glu-sca) levels in serum
Serum GOT1 (UI/ml), GPT (UI/ml)
Time frame
Baseline (before surgery)2
Baseline characterization of Glutamate (Glu) levels in serum
Serum Glutamate (μM/L)
Time frame
Baseline (before surgery)3
Time changes in Glutamate scavengers (Glu-sca) levels in serum
Serum GOT1 (UI/ml), GPT (UI/ml)
Time frame
At 3, 6, 9 months following surgery4
Time changes in Glutamate (Glu) levels in serum
Serum Glutamate (μM/L)
Time frame
At 3, 6, 9 months following surgerySecondary outcomes
1
Characterization of Glutamate scavengers (Glu-sca) levels in cerebrospinal fluid (CSF)
CSF levels GOT1 (UI/ml), GPT (UI/ml)
Time frame
Baseline (before surgery)2
Characterization of Glutamate (Glu) levels in cerebrospinal fluid (CSF)
CSF levels Glutamate (μM/L)
Time frame
Baseline (before surgery)Other outcomes
1
Association between Glutamate metabolism and Glioblastoma molecular signature
Association between Glu and Glu-scavengers' levels and molecular patterns of Glioblastoma as described by 2021 WHO classification
Time frame
Baseline levels of markersSponsors and contacts
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Source ClinicalTrials.gov