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Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

NCT ID: NCT06116903

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-11

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Detection of molecular abnormalities

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

Group Type EXPERIMENTAL

Blood sampling

Intervention Type GENETIC

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

Interventions

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Blood sampling

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

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Limoges

Limoges, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Deluche Elise, MD

Role: primary

Other Identifiers

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87RI22_0011-ExoGLIE

Identifier Type: -

Identifier Source: org_study_id