Metabolomics and Transcriptomics of Low- and High-Grade Gliomas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
The goal of this observational study is to better define the molecular profile of rare brain tumors (gliomas) based on the levels of their metabolites and transcripts (the intermediate step between DNA information and proteins).
The main question it aims to answer is to identify new brain tumour subgroups of clinical relevance that might explain the very different history these patients might follow.
Additionally, studies on gliomas require cellular cultures and animal models for the development of new medications, but these models are still scarce and rudimental for many types of gliomas. The second aim of this study is to implement better models for these tumors, for a more effective development of new medications.
Patients enrolled in this study will not undergo any additional procedures with respect to those necessary for gold-standard management of these brain tumors. A small sample of the resected tumour will be used for advanced analyses investigating the metabolic and transcriptomic profile and used for temptative establishment of cellular cultures and animal models of these pathologies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who sign the informed consent form for study participation
Males and females
Age ≥ 18 years
Patients with a radiological diagnosis of central nervous system enlargement on routine preoperative clinical imaging (MRI/PET) who will attend the OU outpatient clinics or the OGSA Emergency Department and are candidates for surgery
Disqualifiers
Age < 18 years
Subjects unable to understand and freely provide consent to the study
Current pregnancy and/or breastfeeding (self-declaration).
Trial population
Patients affected by brain tumors (IDH-mutant lower grade gliomas and IDH-wild-type GBMs) who access Neurosurgery Department (OR, ER, outpatient clinic) at IRCCS Ospedale Galeazzi Sant'Ambrogio
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
220 Participants
are grouped into 1 trial groupGroup A: Brain tumour patients
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
time from surgery to evidence of radiological progression at MRI
Time frame
(up to 180 months)2
Overall Survival (OS)
Time from surgery to tumor-related death
Time frame
(up to 180 months)Secondary outcomes
1
Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion, EGFR mutation/amplification, TERT promoter mutation, chromosomal aberration +7/-10)
IDH-mutant Astrocytoma vs IDH-mutant 1p/19q codeleted Oligodendroglioma vs IDH-wild-type Glioblastoma (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion, EGFR mutation/amplification, TERT promoter mutation, chromosomal aberration +7/-10)
Time frame
Up to 2 months: From date of surgery to date of complete diagnosis2
Tumor Grade at histology and molecular analysis (EGFR mutation/amplification, TERT promoter mutation, CDKN2A/B deletion)
Tumor grade upon histology and molecular analysis (EGFR mutation/amplification, TERT promoter mutation, CDKN2A/B deletion)
Time frame
Up to 2 months: From surgery to complete history-molecular diagnosisSponsors and contacts
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Source ClinicalTrials.gov