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Determination of Immune Phenotype in Glioblastoma Patients

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

Tracking Information
First Submitted Date April 19, 2016
First Posted Date April 26, 2016
Last Update Posted Date October 27, 2017
Actual Study Start Date March 1, 2016
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2016)
Overall survival [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2016)
  • Progression free survival [ Time Frame: 3 months ]
  • Quality of life [ Time Frame: 3 months ]
  • Karnofsky performance score [ Time Frame: 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Immune Phenotype in Glioblastoma Patients
Official Title Determination of Immune Phenotype in Glioblastoma Patients
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Peripheral Blood Mononuclear Cell (PBMC), Plasma, Tumor tissue, DNA, RNA, miRNA
Sampling Method Probability Sample
Study Population Adult glioblastoma multiforme
Condition Glioblastoma Multiforme
Intervention Procedure: Surgery
Tumor resection
Study Groups/Cohorts
  • Isocitrate dehydrogenase - 1 mutated
    Immunophenotype of Glioblastoma and correlation with outcome
    Intervention: Procedure: Surgery
  • Isocitrate dehydrogenase - 1 wild type
    Immunophenotype of Glioblastoma and correlation with outcome
    Intervention: Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 25, 2016)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult glioblastoma multiforme

Exclusion Criteria:

  • pregnancy, unable to give consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02751138
Other Study ID Numbers University Hospital Ulm
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Immune phenotypes of glioma patients included and clinical follow-up
Responsible Party Andrej Pala, University of Ulm
Study Sponsor University of Ulm
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Ulm
Verification Date October 2017