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Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116903
Acronym
ExoGLIE
Enrollment
60
Registered
2023-11-03
Start date
2024-04-11
Completion date
2025-12-15
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

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.

Interventions

GENETICBlood sampling

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analyse Next-generation sequencing (NGS)3 monthsHigher proportion of contributory samples identified by NGS analysis (via exosomes) compared to that of FMI (Foundation Medicine International) test (at inclusion)

Secondary

MeasureTime frameDescription
Expression of biomarkers3 monthsLevel of expression of biomarkers, for the same patient, by molecular analysis of exosomes and blood sampling according to the FMI test protocol
Molecular alterations3 monthsModification or not modification of the profile of the molecular alterations
carbon footprint3 monthsEvaluation of the carbon footprint for each of the 2 techniques (NGS via exosomes and FMI test)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026