Gene Expression, Immunological Status and Metabolome in Glioma Patients

February 6, 2012 updated by: Tamara Lah Turnsek, National Institute of Biology, Slovenia

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 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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tamara Lah Turnšek, PhD
  • Phone Number: +386-59-23-27-03
  • Email: tamara.lah@nib.si

Study Locations

      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Blood Transfusion Centre of Slovenia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Primož Rožman, MD, PhD
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Department of Neurosurgery, University Medical Centre Ljubljana
        • Contact:
          • Marjan Koršič, MD, PhD
        • Principal Investigator:
          • Marjan Koršič, MD, PhD
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • National Institute of Biology
        • Contact:
        • Principal Investigator:
          • Kristina Gruden, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Glioma patients treated with surgical resection of the tumor

Description

Inclusion Criteria:

  • malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria:

  • pregnancy
  • metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glioma patients
Patients will be treated with the standard surgical therapy - glioma resection.
Blood samples used for measuring studied parameters will be taken within 10 days before surgery, one day after surgery and once more within 10 days following the operative procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transcriptome profile of CD4+ T and CD56+ NK cells
Time Frame: within 10 days before surgery
within 10 days before surgery
Transcriptome profile of CD4+ T and CD56+ NK cells
Time Frame: one day after surgery
one day after surgery
Transcriptome profile of CD4+ T and CD56+ NK cells
Time Frame: within 10 days after surgery
within 10 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Metabolite profiling in blood plasma samples
Time Frame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
Lymphocyte subpopulation assessment in peripheral blood samples
Time Frame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
within 10 days before surgery, one day after surgery and once more within 10 days after surgery
Antibody profiling in blood plasma samples
Time Frame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
within 10 days before surgery, one day after surgery and once more within 10 days after surgery
miRNA profiling in blood plasma samples
Time Frame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
Proteomic analysis of blood plasma samples
Time Frame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
within 10 days before surgery, one day after surgery and once more within 10 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Tamara Lah Turnšek, PhD, National Institute of Biology, Ljubljana, Slovenia
  • Principal Investigator: Kristina Gruden, PhD, National Institute of Biology, Ljubljana, Slovenia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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