Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Study Overview
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Brief Summary
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The purpose of this pilot study is that exosomes constitute a more interesting support for analyzes allowing a broader screening of molecular alterations to be carried out with more reliable, more sensitive and more efficient results than the reference Foundation One Liquid CDx test.

Detailed Description
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Gliomas are the most common primary brain tumors in adults. The heterogeneity of tumors, the lack of reliable criteria for identifying different subtypes make their histopathological diagnosis and their management complex. The molecular profiling from circulating exosomes is one of the most promising approaches to better characterize gliomas. We will demonstrate the superiority of detection by NGS of molecular abnormalities present in exosomes from glioblastomas, compared to detection by the Foundation One Liquid CDx test on ctDNA.

Official Title
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Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Conditions
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Glioma

Intervention / Treatment
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* Genetic: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject of both sexes at least 18 years of age with glioblastoma. Patient for whom an FMI test is indicated, progressing after a 1st line following the chemotherapy and radiotherapy protocol (STUPP protocol) Patient affiliated to French social security Exclusion Criteria: Patient included in another research protocol using an experimental molecule. Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the patient from adhering to the protocol or completing the study per protocol Patient under legal protection, guardianship or curatorship Patient with active malignancy or a previous malignancy within the past 5 years; except for patient with resected Basocarcinoma and resected carcinoma in-situ of the cervix.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Detection of molecular abnormalities<br>Blood samples will be taken from 2 + 3 Cell-Free DNA Collection tubes (Roche): for the comparative performance of the two methods (main objective) 3 Cell-Free DNA Collection tubes will be collected at 3 months (post chemotherapy) to evaluate the clinical relevance of a new analysis of molecular alterations on exosomes | Genetic: Blood sampling<br>* Blood sampling for testing of the detection of molecular abnormalities in exosomes of glial tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse Next-generation sequencing (NGS) | Higher proportion of contributory samples identified by NGS analysis (via exosomes) compared to that of FMI (Foundation Medicine International) test (at inclusion) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of biomarkers | Level of expression of biomarkers, for the same patient, by molecular analysis of exosomes and blood sampling according to the FMI test protocol | 3 months | 
| Molecular alterations | Modification or not modification of the profile of the molecular alterations | 3 months | 
| carbon footprint | Evaluation of the carbon footprint for each of the 2 techniques (NGS via exosomes and FMI test) | 3 months |