Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioma
- Sponsor
- University Hospital, Limoges
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Analyse Next-generation sequencing (NGS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Analyse Next-generation sequencing (NGS)
Time Frame: 3 months
Higher proportion of contributory samples identified by NGS analysis (via exosomes) compared to that of FMI (Foundation Medicine International) test (at inclusion)
Secondary Outcomes
- Molecular alterations(3 months)
- Expression of biomarkers(3 months)
- carbon footprint(3 months)