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NCT02751138 Clinical Trial

Determination of Immune Phenotype in Glioblastoma Patients

Glioblastoma Multiforme Clinical Trial

Official title:
Determination of Immune Phenotype in Glioblastoma Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02751138
Other study ID # University Hospital Ulm
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date January 1, 2023

Study information
Verified date May 2023
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult glioblastoma multiforme Exclusion Criteria: - pregnancy, unable to give consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgery
Tumor resection

Locations
Country Name City State
Germany Department of Neurosurgery Ulm

Sponsors (1)
Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 3 months
Secondary Progression free survival 3 months
Secondary Karnofsky performance score 3 months
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