In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma

NCT03481231 | Completed

• 1 other identifier: 2017-A00531-52
• Study Type: observational
• Target: 160
• Locations: 2 countries
• Sites: 5

Brief Summary

Glioblastoma (GBM) is the most frequent brain tumor. Currently survival is poor and few treatments are available. Recent data show that there is no immune privilege of the central nervous system (CNS) and that GBM are invaded by effector CD8 T cells, letting us hypothesis that GBM growth is dependent of immunosurveillance. The aim of this study is to better understand the antitumor immune response against GBM to unravel new effectors and immunosuppressive pathways important for the regulation of anticancer immunity and to discover new immune activating strategies with the objectives to isolate subgroups of GBMs that could benefit from an immunotherapy approach. To achieve this goal, GBM tumor samples and a blood sample will be collected during the initial tumor resection. The sites involved in the recruitment of the patients will be the neurosurgical teams in Brussel, Dijon, Nantes and Padova.

Conditions

Glioblastoma

Keywords

immunotherapy; tumors and blood samples

Outcome Measures

Primary Outcomes (1)

• overall survival

  Determination for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters

  24 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with a glioblastoma

You may qualify if:

• Patients with newly diagnosed, brain tumor
• Gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron.
• Subjects ≥18 and ≤75 years of age at surgery
• Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
• Confirmation of the diagnosis of grade IV GBM by the local pathologist with an independent neuropathologist who will review this diagnosis
• Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent temozolomide chemotherapy.
• Tumor biopsy for biological analysis has to be performed before using ultrasonic surgery

You may not qualify if:

• Patient with other type of primary brain tumor or metastases
• Patients with only biopsy performed for the diagnosis
• Subjects under guardianship, curatorship or judicial protection
• Female subjects who are pregnant or breast-feeding

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (5)

Centre Georges François Leclerc

Dijon, 21000, France

Location

CHU de DIJON

Dijon, 21000, France

Location

CHU de Nantes

Saint-Herblain, 44800, France

Location

Università di Florence

Florence, Italy

Location

Azienda Ospedaliera Università di Padova

Padua, 35128, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

24 ml blood sample + tumor samples

MeSH Terms

Conditions

Glioblastoma; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: September 13, 2020
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

FR (3); IT (2)