Trial record 5 of 465 for:    glioma | Open Studies

Gene Expression, Immunological Status and Metabolome in Glioma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by National Institute of Biology, Slovenia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Tamara Lah Turnsek, National Institute of Biology, Slovenia
ClinicalTrials.gov Identifier:
NCT01525459
First received: January 20, 2012
Last updated: February 6, 2012
Last verified: February 2012
  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 National Institute of Biology, Slovenia:

Primary Outcome Measures:
  • Transcriptome profile of CD4+ T and CD56+ NK cells [ Time Frame: within 10 days before surgery ] [ Designated as safety issue: No ]
  • Transcriptome profile of CD4+ T and CD56+ NK cells [ Time Frame: one day after surgery ] [ Designated as safety issue: No ]
  • Transcriptome profile of CD4+ T and CD56+ NK cells [ Time Frame: within 10 days after surgery ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525459

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

Locations
Slovenia
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         
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         
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
Study First Received: January 20, 2012
Last Updated: February 6, 2012
Health Authority: Slovenia: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 28, 2014