Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Glioma Clinical Trial

— ExoGLIE  

Official title:

Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116903
• Other study ID #: 87RI22_0011-ExoGLIE
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Genetic:
• Blood sampling
Blood sampling for testing of the detection of molecular abnormalities in exosomes of glial tumors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Molecular alterations	Modification or not modification of the profile of the molecular alterations	3 months
Secondary	carbon footprint	Evaluation of the carbon footprint for each of the 2 techniques (NGS via exosomes and FMI test)	3 months