Gene Expression, Immunological Status and Metabolome in Glioma Patients

• Conditions: Glioma
• Interventions: Procedure: Glioma resection; Other: Blood sampling

• Registration Number: NCT01525459
• Lead Sponsor: National Institute of Biology, Slovenia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-31
• Status Verified: 2012-02
• Study First Posted: 2012-02-03
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-07
• Primary Completion: 2012-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria

• pregnancy
• metastases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glioma patients	Blood sampling	-
Glioma patients	Glioma resection	-

Primary Outcome Measures

Name	Time	Method
Transcriptome profile of CD4+ T and CD56+ NK cells	within 10 days after surgery

Secondary Outcome Measures

Name	Time	Method
Lymphocyte subpopulation assessment in peripheral blood samples	within 10 days before surgery, one day after surgery and once more within 10 days after surgery
Proteomic analysis of blood plasma 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

Trial Locations

Locations (3)

Blood Transfusion Centre of Slovenia; 🇸🇮 Ljubljana, Slovenia

Department of Neurosurgery, University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia

National Institute of Biology; 🇸🇮 Ljubljana, Slovenia