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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07173829
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Bordeaux
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Julien ENGELHARDT, DrMathieu LARROQUETTE, DrGuillaume CHOTARD, DrLionel COUZI, PrAndreas BIKFALVI, PrCharles DUPIN, DrVéronique VENDRELY, PrJulie DECHANET-MERVILLE, DrThomas DAUBON, Dr
Principal Investigator Affiliation	University Hospital, BordeauxUniversity Hospital, BordeauxUniversity Hospital, BordeauxBordeaux university Hospital, Bordeaux UniversityUniversity of BordeauxUniversity Hospital, BordeauxBordeaux university Hospital, Bordeaux UniversityUniversity of BordeauxUniversity of Bordeaux
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

: Recruited patient

Glioblastoma patient with indication for neurosurgery

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Julien ENGELHARDT, Dr

[email protected]

05 56 79 55 77

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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