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Determination of Immune Phenotype in Glioblastoma Patients

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ClinicalTrials.gov Identifier: NCT02751138
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Andrej Pala, 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.

Condition or disease Intervention/treatment
Glioblastoma Multiforme Procedure: Surgery

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Determination of Immune Phenotype in Glioblastoma Patients
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Isocitrate dehydrogenase - 1 mutated
Immunophenotype of Glioblastoma and correlation with outcome
Procedure: Surgery
Tumor resection

Isocitrate dehydrogenase - 1 wild type
Immunophenotype of Glioblastoma and correlation with outcome
Procedure: Surgery
Tumor resection




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 months ]
  2. Quality of life [ Time Frame: 3 months ]
  3. Karnofsky performance score [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
Peripheral Blood Mononuclear Cell (PBMC), Plasma, Tumor tissue, DNA, RNA, miRNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult glioblastoma multiforme
Criteria

Inclusion Criteria:

  • adult glioblastoma multiforme

Exclusion Criteria:

  • pregnancy, unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751138


Contacts
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Contact: Andrej Pala, MD +4982219628866 andrej.pala@gmail.com
Contact: Marion Schneider, Prof +4973150060080 marion.schneider@uni-ulm.de

Locations
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Germany
Department of Neurosurgery Recruiting
Ulm, Germany, 89081
Contact: Monika Deininger    +4982219622504    monika.deininger@bkh-guenzburg.de   
Sponsors and Collaborators
University of Ulm

Additional Information:

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Responsible Party: Andrej Pala, MD, University of Ulm
ClinicalTrials.gov Identifier: NCT02751138     History of Changes
Other Study ID Numbers: University Hospital Ulm
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Immune phenotypes of glioma patients included and clinical follow-up

Keywords provided by Andrej Pala, University of Ulm:
Immune phenotype
Cytokines
Genetic aberration
Overall survival
Progression free survival

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue