Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Not Applicable

Recruiting

• Conditions: Glioma
• Interventions: Genetic: Blood sampling

• Registration Number: NCT06116903
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-03
• Study Start: 2024-04-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-05-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Detection of molecular abnormalities	Blood sampling	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

Primary Outcome Measures

Name	Time	Method
Analyse Next-generation sequencing (NGS)	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU de Limoges; 🇫🇷 Limoges, France