NCT03481231Completed
In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma
Source: ClinicalTrials.gov · Last updated 17 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 160 (actual)
- First submitted
- 22 Mar 2018
- Start date
- 13 Sept 2020
- Primary completion date
- 14 Sept 2024
- Lead sponsor
- Centre Georges Francois Leclerc
- Diseases
- Glioblastoma
- NCT number
- NCT03481231
What you commit to
- Study type: Observational
- Participants enrolled: 160
- From 13 Sept 2020 to the primary completion date, 14 Sept 2024
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de DIJON Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Università di Florence Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda Ospedaliera Università di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.