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Gene Expression, Immunological Status and Metabolome in Glioma Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Tamara Lah Turnsek, National Institute of Biology, Slovenia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01525459
First Posted: February 3, 2012
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Tamara Lah Turnsek, National Institute of Biology, Slovenia
  Purpose

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).


Condition Intervention
Glioma Procedure: Glioma resection Other: Blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Tamara Lah Turnsek, National Institute of Biology, Slovenia:

Primary Outcome Measures:
  • Transcriptome profile of CD4+ T and CD56+ NK cells [ Time Frame: within 10 days before surgery ]
  • Transcriptome profile of CD4+ T and CD56+ NK cells [ Time Frame: one day after surgery ]
  • Transcriptome profile of CD4+ T and CD56+ NK cells [ Time Frame: within 10 days after surgery ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood, blood plasma, peripheral blood mononuclear cells, CD4+ T cells, CD56+ NK cells

Estimated Enrollment: 16
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Glioma patients Procedure: Glioma resection
Patients will be treated with the standard surgical therapy - glioma resection.
Other: Blood sampling
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Glioma patients treated with surgical resection of the tumor
Criteria

Inclusion Criteria:

  • malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria:

  • pregnancy
  • metastases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525459


Contacts
Contact: Tamara Lah Turnšek, PhD +386-59-23-27-03 tamara.lah@nib.si

Locations
Slovenia
Blood Transfusion Centre of Slovenia Recruiting
Ljubljana, Slovenia, 1000
Contact: Primož Rožman, MD, PhD    +386-1-5438-100    primoz.rozman@ztm.si   
Contact: Matija Veber, dipl. biotech.    +386-51-649-350    matija.veber@ztm.si   
Principal Investigator: Primož Rožman, MD, PhD         
Department of Neurosurgery, University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Marjan Koršič, MD, PhD         
Principal Investigator: Marjan Koršič, MD, PhD         
National Institute of Biology Recruiting
Ljubljana, Slovenia, 1000
Contact: Tamara Lah Turnšek, PhD    +386-59-23-27-03    tamara.lah@nib.si   
Principal Investigator: Kristina Gruden, PhD         
Sponsors and Collaborators
National Institute of Biology, Slovenia
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
Investigators
Study Chair: Tamara Lah Turnšek, PhD National Institute of Biology, Ljubljana, Slovenia
Principal Investigator: Kristina Gruden, PhD National Institute of Biology, Ljubljana, Slovenia
  More Information

Additional Information:
Publications:
Responsible Party: Tamara Lah Turnsek, Director of the National Institute of Biology, Slovenia, National Institute of Biology, Slovenia
ClinicalTrials.gov Identifier: NCT01525459     History of Changes
Other Study ID Numbers: MNC-Glioma-1-4
First Submitted: January 20, 2012
First Posted: February 3, 2012
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Tamara Lah Turnsek, National Institute of Biology, Slovenia:
Glioma
PBMC subpopulations
Gene expression
Metabolomics
Immunological status
miRNA
Proteomics

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue