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Trial Title:
Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes
NCT ID:
NCT06116903
Condition:
Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Blood sampling
Description:
Blood sampling for testing of the detection of molecular abnormalities in exosomes of
glial tumors
Arm group label:
Detection of molecular abnormalities
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 15, 2023
Completion date:
December 15, 2025
Lead sponsor:
Agency:
University Hospital, Limoges
Agency class:
Other
Source:
University Hospital, Limoges
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116903
