Status:
COMPLETED
In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
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)...
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 Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 14 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03481231
Start Date
September 13 2020
End Date
September 14 2024
Last Update
February 17 2025
Active Locations (5)
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1
Centre Georges François Leclerc
Dijon, France, 21000
2
CHU de DIJON
Dijon, France, 21000
3
CHU de Nantes
Saint-Herblain, France, 44800
4
Università di Florence
Florence, Italy