Gene Expression, Immunological Status and Metabolome in Glioma Patients

NCT ID: NCT01525459

Last Updated: 2012-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glioma patients

Glioma resection

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type 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.

Interventions

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Glioma resection

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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria

* pregnancy
* metastases
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blood Transfusion Centre of Slovenia

OTHER_GOV

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role collaborator

National Institute of Biology, Slovenia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tamara Lah Turnsek

Director of the National Institute of Biology, Slovenia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamara Lah Turnšek, PhD

Role: STUDY_CHAIR

National Institute of Biology, Ljubljana, Slovenia

Kristina Gruden, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Biology, Ljubljana, Slovenia

Locations

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Blood Transfusion Centre of Slovenia

Ljubljana, , Slovenia

Site Status RECRUITING

Department of Neurosurgery, University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

National Institute of Biology

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Tamara Lah Turnšek, PhD

Role: CONTACT

+386-59-23-27-03

Facility Contacts

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Primož Rožman, MD, PhD

Role: primary

+386-1-5438-100

Matija Veber, dipl. biotech.

Role: backup

+386-51-649-350

Marjan Koršič, MD, PhD

Role: primary

Tamara Lah Turnšek, PhD

Role: primary

+386-59-23-27-03

References

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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.

Reference Type BACKGROUND
PMID: 22253695 (View on PubMed)

Related Links

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http://www.nib.si

Official internet page of the Slovenian National Institute of Biology

http://systher.biologie.hu-berlin.de

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

Other Identifiers

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MNC-Glioma-1-4

Identifier Type: -

Identifier Source: org_study_id

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