Gene Expression, Immunological Status and Metabolome in Glioma Patients

Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01525459
• Other study ID #: MNC-Glioma-1-4
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2012
• Last updated: February 6, 2012
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: National Institute of Biology, Slovenia
• Contact: Tamara Lah Turnšek, PhD
• Phone: +386-59-23-27-03
• Email: tamara.lah[@]nib.si
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria:

• pregnancy

• metastases

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioma

Intervention

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.

Locations

Country	Name	City	State
Slovenia	Blood Transfusion Centre of Slovenia	Ljubljana
Slovenia	Department of Neurosurgery, University Medical Centre Ljubljana	Ljubljana
Slovenia	National Institute of Biology	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Biology, Slovenia	Blood Transfusion Centre of Slovenia, University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & 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, Kneževic M, Rožman 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptome profile of CD4+ T and CD56+ NK cells		within 10 days before surgery	No
Primary	Transcriptome profile of CD4+ T and CD56+ NK cells		one day after surgery	No
Primary	Transcriptome profile of CD4+ T and CD56+ NK cells		within 10 days after surgery	No
Secondary	Metabolite profiling in blood plasma samples		within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery	No
Secondary	Lymphocyte subpopulation assessment in peripheral blood samples		within 10 days before surgery, one day after surgery and once more within 10 days after surgery	No
Secondary	Antibody profiling in blood plasma samples		within 10 days before surgery, one day after surgery and once more within 10 days after surgery	No
Secondary	miRNA profiling in blood plasma samples		within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery	No
Secondary	Proteomic analysis of blood plasma samples		within 10 days before surgery, one day after surgery and once more within 10 days after surgery	No

External Links

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