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

October 16, 2023 updated by: Centre Georges Francois Leclerc

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Primary objective :

The primary objective is to determine for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters

Secondary objectives :

To identify the best combination of in vivo immune parameters that is predictive of 1-year overall survival To determine the impact of immune parameters on overall survival Create a collection of biological samples

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Dijon, France, 21000
        • Centre Georges François Leclerc
      • Dijon, France, 21000
        • CHU de Dijon
      • Saint-Herblain, France, 44800
        • CHU de Nantes
  • Italy
      • Florence, Italy
        • Università di Florence
      • Padova, Italy, 35128
        • Azienda Ospedaliera Universita di Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with a glioblastoma

Description

Inclusion Criteria:

  1. Patients with newly diagnosed, brain tumor
  2. Gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron.
  3. Subjects ≥18 and ≤75 years of age at surgery
  4. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
  5. Confirmation of the diagnosis of grade IV GBM by the local pathologist with an independent neuropathologist who will review this diagnosis
  6. 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.
  7. Tumor biopsy for biological analysis has to be performed before using ultrasonic surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2020

Primary Completion (Estimated)

September 14, 2024

Study Completion (Estimated)

September 14, 2024

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A00531-52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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