Determination of Immune Phenotype in Glioblastoma Patients

NCT ID: NCT02751138

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2023-01-01

Brief Summary

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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

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Conditions

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Glioblastoma Multiforme

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Isocitrate dehydrogenase - 1 mutated

Immunophenotype of Glioblastoma and correlation with outcome

Surgery

Intervention Type PROCEDURE

Tumor resection

Isocitrate dehydrogenase - 1 wild type

Immunophenotype of Glioblastoma and correlation with outcome

Surgery

Intervention Type PROCEDURE

Tumor resection

Interventions

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Surgery

Tumor resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult glioblastoma multiforme

Exclusion Criteria

* pregnancy, unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Andrej Pala

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurosurgery

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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University Hospital Ulm

Identifier Type: -

Identifier Source: org_study_id

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