Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes

NCT06116903 | Recruiting

• 1 other identifier: 87RI22_0011-ExoGLIE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Analyse Next-generation sequencing (NGS)

  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 Outcomes (3)

• Expression of biomarkers

  3 months

• Molecular alterations

  3 months

• carbon footprint

  3 months

Study Arms (1)

Detection of molecular abnormalities

EXPERIMENTAL

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

Interventions

Blood sampling GENETIC

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

Detection of molecular abnormalities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: April 11, 2024
• Primary Completion: May 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)