Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes (ExoGLIE)

December 10, 2024 updated by: University Hospital, Limoges
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Genetic: Blood sampling
Blood sampling for testing of the detection of molecular abnormalities in exosomes of glial tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyse Next-generation sequencing (NGS)
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of biomarkers
Time Frame: 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
3 months
Molecular alterations
Time Frame: 3 months
Modification or not modification of the profile of the molecular alterations
3 months
carbon footprint
Time Frame: 3 months
Evaluation of the carbon footprint for each of the 2 techniques (NGS via exosomes and FMI test)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI22_0011-ExoGLIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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