GliomaNCT01525459
Gene Expression, Immunological Status and Metabolome in Glioma Patients
An observational study of Glioma, run by National Institute of Biology, Slovenia at 3 sites in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Glioma
- What is being tested?
- Glioma resection and Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 3 sitesSlovenia
- Study dates
- Dec 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glioma patients treated with surgical resection of the tumor
Who may be able to join
- malignant glioma = glioblastoma (WHO IV) patients
Who cannot join
- pregnancy
- metastases
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites, 3 recruiting
- Recruiting
Blood Transfusion Centre of Slovenia
Ljubljana, 1000
Primož Rožman, MD, PhD, +386-1-5438-100, primoz.rozman@ztm.si
Matija Veber, dipl. biotech., +386-51-649-350, matija.veber@ztm.si
- Recruiting
Department of Neurosurgery, University Medical Centre Ljubljana
Ljubljana, 1000
Marjan Koršič, MD, PhD
Marjan Koršič, MD, PhD
- Recruiting
National Institute of Biology
Ljubljana, 1000
Tamara Lah Turnšek, PhD, +386-59-23-27-03, tamara.lah@nib.si
Kristina Gruden, PhD
About this study
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
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
- Being tested
- Glioma resection, Blood sampling
- Keywords
- Glioma, PBMC subpopulations, Gene expression, Metabolomics, Immunological status, miRNA, Proteomics
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glioma resectionProcedure or surgery
Patients will be treated with the standard surgical therapy - glioma resection.
Blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glioma patients | Not described Receives: Procedure: Glioma resection; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptome profile of CD4+ T and CD56+ NK cells
Measured: within 10 days before surgery
Transcriptome profile of CD4+ T and CD56+ NK cells
Measured: one day after surgery
Transcriptome profile of CD4+ T and CD56+ NK cells
Measured: within 10 days after surgery
Secondary outcomes (5)
Metabolite profiling in blood plasma samples
Measured: 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
Measured: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
Antibody profiling in blood plasma samples
Measured: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
miRNA profiling in blood plasma samples
Measured: within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery
Proteomic analysis of blood plasma samples
Measured: within 10 days before surgery, one day after surgery and once more within 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startDec 2010
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Biology, Slovenia
- Sponsor type
- Other government
- Collaborators
- Blood Transfusion Centre of Slovenia, University Medical Centre Ljubljana
- Responsible party
- Principal investigator, Tamara Lah Turnsek, National Institute of Biology, Slovenia
- Investigators
- Tamara Lah Turnšek, PhD, Study chair, National Institute of Biology, Ljubljana, SloveniaKristina Gruden, PhD, Principal investigator, National Institute of Biology, Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525459
- Sponsor's protocol ID
- MNC-Glioma-1-4
- Status last verified
- Feb 2012
- First submitted
- 20 Jan 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22253695
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01525459
- Acronym / sponsor ID
- MNC-Glioma-1-4
- Conditions
- Glioma
- Keywords
- Glioma, PBMC subpopulations, Gene expression, Metabolomics, Immunological status, miRNA, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National Institute of Biology, SloveniaOther government
- Collaborators
- Blood Transfusion Centre of Slovenia, University Medical Centre Ljubljana
- Study start
- Dec 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioma patients | – | Procedure: Glioma resection, Other: Blood sampling |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glioma patients treated with surgical resection of the tumor
Key inclusion criteria (1 listed)
- malignant glioma = glioblastoma (WHO IV) patients
Key exclusion criteria (2 listed)
- pregnancy
- metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glioma resectionPatients will be treated with the standard surgical therapy - glioma resection. | Procedure or surgery | Glioma patients |
| Blood samplingBlood 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. | Other | Glioma patients |
Primary outcome
Transcriptome profile of CD4+ T and CD56+ NK cells
Time frame: within 10 days before surgery
Transcriptome profile of CD4+ T and CD56+ NK cells
Time frame: one day after surgery
Transcriptome profile of CD4+ T and CD56+ NK cells
Time frame: within 10 days after surgery
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
- Background: PubMed 22253695Gruden 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.
- Official internet page of the Slovenian National Institute of BiologyLink provided by the sponsor.
- Official internet page of the project SYSTHER (Systems Biology Tools Development For Cell Therapy And Drug Development)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Lah Turnšek, PhD study chair
National Institute of Biology, Ljubljana, Slovenia
Kristina Gruden, PhD principal investigator
National Institute of Biology, Ljubljana, Slovenia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by National Institute of Biology, Slovenia at 3 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamara Lah Turnšek, PhD (+386-59-23-27-03, tamara.lah@nib.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptome profile of CD4+ T and CD56+ NK cells (time frame: within 10 days before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.