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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01525459
Other study ID # MNC-Glioma-1-4
Secondary ID
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


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
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