Determination of Immune Phenotype in Glioblastoma Patients

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Procedure: Surgery

• Registration Number: NCT02751138
• Lead Sponsor: University of Ulm

Brief Summary

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the current observational study is to determine immune phenotypes in individual patients with GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as progression free and overall survival, Karnofsky index (progression free survival (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual GBM patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-26
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• adult glioblastoma multiforme

Exclusion Criteria

• pregnancy, unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Isocitrate dehydrogenase - 1 mutated	Surgery	Immunophenotype of Glioblastoma and correlation with outcome
Isocitrate dehydrogenase - 1 wild type	Surgery	Immunophenotype of Glioblastoma and correlation with outcome

Primary Outcome Measures

Name	Time	Method
Overall survival	3 months

Secondary Outcome Measures

Name	Time	Method
Progression free survival	3 months
Karnofsky performance score	3 months

Trial Locations

Locations (1)

Department of Neurosurgery; 🇩🇪 Ulm, Germany