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Clinical Trials/NCT01525459
NCT01525459
Unknown
Not Applicable

Monitoring and Analysis of Gene Expression, Immunological Status and Metabolome in Peripheral Blood Mononuclear Cells and Their Specific Subpopulations (CD4+ T Cells and CD56+ NK Cells) in Surgically Treated Glioma Patients

National Institute of Biology, Slovenia3 sites in 1 country16 target enrollmentDecember 2010
ConditionsGlioma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioma
Sponsor
National Institute of Biology, Slovenia
Enrollment
16
Locations
3
Primary Endpoint
Transcriptome profile of CD4+ T and CD56+ NK cells
Last Updated
14 years ago

Overview

Brief Summary

Study on glioma patients treated with brain surgery is focusing on the analysis of their transcriptome expression profile measured in two immune cell populations, CD4+ T cells and CD56+ NK cells. The results of analysis will be compared to the reference data of healthy population. Furthermore, the metabolomic and immunological status will also be monitored and compared to healthy group reference data, before and after the surgery*. With comparative crossomics analysis the investigators intend to possibly identify new diagnostic and prognostic biological markers for the relapse of the disease. The results are expected to convey a deeper insight into pathophysiology of the glioma as well as into the mechanisms of the current surgical therapy.

* The healthy reference data have been published in collaborative efforts of BTC, UMC and NIB (Gruden et al. 2012).

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
December 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Institute of Biology, Slovenia
Responsible Party
Principal Investigator
Principal Investigator

Tamara Lah Turnsek

Director of the National Institute of Biology, Slovenia

National Institute of Biology, Slovenia

Eligibility Criteria

Inclusion Criteria

  • malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria

  • pregnancy
  • metastases

Outcomes

Primary Outcomes

Transcriptome profile of CD4+ T and CD56+ NK cells

Time Frame: within 10 days after surgery

Secondary Outcomes

  • Proteomic analysis of blood plasma samples(within 10 days before surgery, one day after surgery and once more within 10 days after surgery)
  • Lymphocyte subpopulation assessment in peripheral blood samples(within 10 days before surgery, one day after surgery and once more within 10 days after surgery)
  • Metabolite profiling in blood plasma samples(within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery)
  • Antibody profiling in blood plasma samples(within 10 days before surgery, one day after surgery and once more within 10 days after surgery)
  • miRNA profiling in blood plasma samples(within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery)

Study Sites (3)

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