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Recruiting NCT07173829

A Study to Better Understand the Biological and Molecular Mechanisms Involved in Glioblastoma Recurrence and Progression

Observational Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: samples.
Who it may be relevant to
Registry conditions: Glioblastoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Study to Better Understand the Molecular, Immune and Metabolic Mechanisms Involved in Glioblastoma Recurrence and Progression, in the Aim to Identify New Therapeutic Targets and to Improve Current Therapies

Overview

BORDEAUX-GLIO is a prospective, monocentric study which will describe the molecular, immune and metabolic pathways involved in the progression and relapse of glioblastoma, using blood and tumor samples from patients who have undergone surgery for newly diagnosed or recurrent glioblastoma in the center.

Detailed description

Glioblastoma is the most common and aggressive primary brain tumor in adults, whose relapse is almost systematic despite surgery, radiation therapy and temozolomide (STUPP protocol). Several clinical trials evaluating targeted therapy and immune checkpoint inhibitors have led to disappointed results. There is an unmet need to better understand the molecular and immune mechanisms underlying the invasion and progression of these tumors, in order to identify new therapeutic targets. The Bordeaux University Hospital is a leading French treatment center for glioblastoma, providing a large number of biological samples that can be analyzed at the molecular, immune and metabolic levels by specialized local teams.

Tumor tissue will be collected during patient surgery from primitive or recurrent glioblastoma, as well as blood samples, to perform transcriptomic and metabolomic analysis, including spatial transcriptomic and metabolomic, ex vivo generation of γδT lymphocytes and patient-derived xenografts.

A secondary objective is to develop, in preclinical models, innovative drugs with radiosensitizing effect and a γδT cell immunotherapy active against glioblastoma.

Interventions

  • Other samples
    A 50 ml blood sample will be taken from the patient before the operation, and two 0.3 cm3 tumor samples will be taken during the operation from the resected tumor.

Primary outcome measures

  • Molecular mechanism [Time frame: at inclusion (T0)]
  • Metabolic mechanism [Time frame: at inclusion (T0)]
  • Immune mechanism [Time frame: at inclusion (T0)]

Eligibility criteria

Inclusion criteria

  • Patients of 18 years or older, with highly suspected glioblastoma on neuro-imagery
  • Planned surgical tumor resection,
  • No objection to participate in research
  • Signed genetic consent

Exclusion criteria

  • Patients under guardianship, curatorship or protective supervision
  • Taking immunosuppressants
  • Pregnant or breast-feeding women
  • Patients deprived of their liberty by judicial or administrative decision, or under psychiatric care

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de Bordeaux — Bordeaux

Identifiers

NCT: NCT07173829 · CHUBX 2023/06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗