Gene Expression, Immunological Status and Metabolome in Glioma Patients

NCT01525459 | Unknown

• 1 other identifier: MNC-Glioma-1-4
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

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).

Conditions

Glioma

Keywords

Glioma; PBMC subpopulations; Gene expression; Metabolomics; Immunological status; miRNA; Proteomics

Outcome Measures

Primary Outcomes (3)

• Transcriptome profile of CD4+ T and CD56+ NK cells

  within 10 days before surgery

• Transcriptome profile of CD4+ T and CD56+ NK cells

  one day after surgery

• Transcriptome profile of CD4+ T and CD56+ NK cells

  within 10 days after surgery

Secondary Outcomes (5)

• Metabolite profiling in blood plasma samples

  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

  within 10 days before surgery, one day after surgery and once more within 10 days after 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

• Proteomic analysis of blood plasma samples

  within 10 days before surgery, one day after surgery and once more within 10 days after surgery

Study Arms (1)

Glioma patients

Procedure: Glioma resection; Other: Blood sampling

Interventions

Glioma resection PROCEDURE

Patients will be treated with the standard surgical therapy - glioma resection.

Glioma patients

Blood sampling OTHER

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.

Glioma patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Glioma patients treated with surgical resection of the tumor

You may qualify if:

• malignant glioma = glioblastoma (WHO IV) patients

You may not qualify if:

• pregnancy
• metastases

Sponsors & Collaborators

• National Institute of Biology, Slovenia: lead
• Blood Transfusion Centre of Slovenia: collaborator
• University Medical Centre Ljubljana: collaborator

Study Sites (3)

Blood Transfusion Centre of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

Department of Neurosurgery, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

National Institute of Biology

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (1)

• 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.

  PMID: 22253695 BACKGROUND

Related Links

• Official internet page of the Slovenian National Institute of Biology
• Official internet page of the project SYSTHER (Systems Biology Tools Development For Cell Therapy And Drug Development)

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, blood plasma, peripheral blood mononuclear cells, CD4+ T cells, CD56+ NK cells

MeSH Terms

Conditions

Glioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tamara Lah Turnšek, PhD

  National Institute of Biology, Ljubljana, Slovenia

  STUDY CHAIR

• Kristina Gruden, PhD

  National Institute of Biology, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Lah Turnšek, PhD

CONTACT

+386-59-23-27-03; tamara.lah@nib.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the National Institute of Biology, Slovenia

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: February 3, 2012
• Study Start: December 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

SL (3)