- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525459
Gene Expression, Immunological Status and Metabolome in Glioma Patients
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tamara Lah Turnšek, PhD
- Phone Number: +386-59-23-27-03
- Email: tamara.lah@nib.si
Study Locations
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-
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Ljubljana, Slovenia, 1000
- Recruiting
- Blood Transfusion Centre of Slovenia
-
Contact:
- Primož Rožman, MD, PhD
- Phone Number: +386-1-5438-100
- Email: primoz.rozman@ztm.si
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Contact:
- Matija Veber, dipl. biotech.
- Phone Number: +386-51-649-350
- Email: matija.veber@ztm.si
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Principal Investigator:
- Primož Rožman, MD, PhD
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Ljubljana, Slovenia, 1000
- Recruiting
- Department of Neurosurgery, University Medical Centre Ljubljana
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Contact:
- Marjan Koršič, MD, PhD
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Principal Investigator:
- Marjan Koršič, MD, PhD
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Ljubljana, Slovenia, 1000
- Recruiting
- National Institute of Biology
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Contact:
- Tamara Lah Turnšek, PhD
- Phone Number: +386-59-23-27-03
- Email: tamara.lah@nib.si
-
Principal Investigator:
- Kristina Gruden, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- malignant glioma = glioblastoma (WHO IV) patients
Exclusion Criteria:
- pregnancy
- metastases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Glioma patients
|
Patients will be treated with the standard surgical therapy - glioma resection.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transcriptome profile of CD4+ T and CD56+ NK cells
Time Frame: within 10 days before surgery
|
within 10 days before surgery
|
Transcriptome profile of CD4+ T and CD56+ NK cells
Time Frame: one day after surgery
|
one day after surgery
|
Transcriptome profile of CD4+ T and CD56+ NK cells
Time Frame: within 10 days after surgery
|
within 10 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
Time Frame: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
|
within 10 days before surgery, one day after surgery and once more within 10 days after surgery
|
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
|
within 10 days before surgery, one day after surgery and once more within 10 days after surgery
|
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
|
within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
|
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
|
within 10 days before surgery, one day after surgery and once more within 10 days after surgery
|
Collaborators and Investigators
Investigators
- Study Chair: Tamara Lah Turnšek, PhD, National Institute of Biology, Ljubljana, Slovenia
- Principal Investigator: Kristina Gruden, PhD, National Institute of Biology, Ljubljana, Slovenia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNC-Glioma-1-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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