Glutamate Excitotoxicity and Its Role in Glioblastoma Biology

Trial Title: Glutamate Excitotoxicity and Its Role in Glioblastoma Biology

NCT ID: NCT05775458

Condition: Brain Tumor, Primary

Conditions: Official terms:
Glioblastoma
Brain Neoplasms

Conditions: Keywords:
Brain tumor
Glutamate

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Blood, CSF and tumor samples
Description: Blood, CSF and brain tissue sampling of Glu and Glu regulatory proteins.
Arm group label: Adult neurosurgical patients

Summary: 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

Detailed description: 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).

Criteria for eligibility:

Study pop:
Adult patients with a brain lesion suspected for GBM, candidate to gross total tumor resection (GTR), followed by radiotherapy and chemotherapy (concomitant and adjuvant).

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: IRCCS San Raffaele Scientific Institute

Address:
City: Milan
Zip: 20132
Country: Italy

Status: Recruiting

Contact:
Last name: Laura Sincinelli

Phone: 003926435568
Email: sincinelli.laura@hsr.it

Start date: June 1, 2020

Completion date: September 30, 2026

Lead sponsor:
Agency: IRCCS San Raffaele
Agency class: Other

Source: IRCCS San Raffaele

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05775458