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NCT Number: NCT06116903

Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Sampling

Genetic

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Molecular alterations

    Time frame: 3 months

    Modification or not modification of the profile of the molecular alterations

  3. carbon footprint

    Time frame: 3 months

    Evaluation of the carbon footprint for each of the 2 techniques (NGS via exosomes and FMI test)

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: ExoGLIE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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