Clinical trial NCT01525459: Gene Expression, Immunological Status and Metabolome in Glioma Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Keywords: Glioma
PBMC subpopulations
Gene expression
Metabolomics
Immunological status
miRNA
Proteomics
Lead sponsor: National Institute of Biology, Slovenia
Sponsor class: OTHER_GOV
Collaborators: name: Blood Transfusion Centre of Slovenia
name: University Medical Centre Ljubljana
First posted: 2012-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Glioma patients treated with surgical resection of the tumor

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).


Eligibility criteria: Inclusion Criteria:

* malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria:

* pregnancy
* metastases

Primary outcomes:
measure: Transcriptome profile of CD4+ T and CD56+ NK cells
timeFrame: within 10 days before surgery
measure: Transcriptome profile of CD4+ T and CD56+ NK cells
timeFrame: one day after surgery
measure: Transcriptome profile of CD4+ T and CD56+ NK cells
timeFrame: within 10 days after surgery
Secondary outcomes:
measure: Metabolite profiling in blood plasma samples
timeFrame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
measure: Lymphocyte subpopulation assessment in peripheral blood samples
timeFrame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
measure: Antibody profiling in blood plasma samples
timeFrame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
measure: miRNA profiling in blood plasma samples
timeFrame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
measure: Proteomic analysis of blood plasma samples
timeFrame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Blood Transfusion Centre of Slovenia
city: Ljubljana
country: Slovenia
facility: Department of Neurosurgery, University Medical Centre Ljubljana
city: Ljubljana
country: Slovenia
facility: National Institute of Biology
Study officials:
affiliation: National Institute of Biology, Ljubljana, Slovenia
name: Tamara Lah Turnšek, PhD
role: STUDY_CHAIR
affiliation: National Institute of Biology, Ljubljana, Slovenia
name: Kristina Gruden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gruden K, Hren M, Herman A, Blejec A, Albrecht T, Selbig J, Bauer C, Schuchardt J, Or-Guil M, Zupancic K, Svajger U, Stabuc B, Ihan A, Kopitar AN, Ravnikar M, Knezevic M, Rozman P, Jeras M. A "crossomics" study analysing variability of different components in peripheral blood of healthy caucasoid individuals. PLoS One. 2012;7(1):e28761. doi: 10.1371/journal.pone.0028761. Epub 2012 Jan 12.