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OpenTrials
Completed

NCT Number: NCT02751138

Determination of Immune Phenotype in Glioblastoma Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult glioblastoma multiforme

Exclusion criteria

  • pregnancy, unable to give consent

Treatment and study plan

Surgery

Procedure

Tumor resection

Primary outcomes

  1. Overall survival

    Time frame: 3 months

Secondary outcomes

  1. Progression free survival

    Time frame: 3 months

  2. Karnofsky performance score

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Apr 26, 2016
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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