Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 8:27 PM
Study NCT ID:
NCT01525459
Status:
UNKNOWN
Last Update Posted:
2012-02-07
First Post:
2012-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression, Immunological Status and Metabolome in Glioma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, blood plasma, peripheral blood mononuclear cells, CD4+ T cells, CD56+ NK cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-06', 'studyFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2012-01-31', 'lastUpdatePostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptome profile of CD4+ T and CD56+ NK cells', 'timeFrame': 'within 10 days before surgery'}, {'measure': 'Transcriptome profile of CD4+ T and CD56+ NK cells', 'timeFrame': 'one day after surgery'}, {'measure': 'Transcriptome profile of CD4+ T and CD56+ NK cells', 'timeFrame': 'within 10 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Metabolite profiling in blood plasma samples', 'timeFrame': 'within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery'}, {'measure': 'Lymphocyte subpopulation assessment in peripheral blood samples', 'timeFrame': 'within 10 days before surgery, one day after surgery and once more within 10 days after surgery'}, {'measure': 'Antibody profiling in blood plasma samples', 'timeFrame': 'within 10 days before surgery, one day after surgery and once more within 10 days after surgery'}, {'measure': 'miRNA profiling in blood plasma samples', 'timeFrame': 'within 10 days before surgery, one day after surgery and once more within 10 days after surgery surgery'}, {'measure': 'Proteomic analysis of blood plasma samples', 'timeFrame': 'within 10 days before surgery, one day after surgery and once more within 10 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glioma', 'PBMC subpopulations', 'Gene expression', 'Metabolomics', 'Immunological status', 'miRNA', 'Proteomics'], 'conditions': ['Glioma']}, 'referencesModule': {'references': [{'pmid': '22253695', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.nib.si', 'label': 'Official internet page of the Slovenian National Institute of Biology'}, {'url': 'http://systher.biologie.hu-berlin.de', 'label': 'Official internet page of the project SYSTHER (Systems Biology Tools Development For Cell Therapy And Drug Development)'}]}, 'descriptionModule': {'briefSummary': '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.\n\n\\* The healthy reference data have been published in collaborative efforts of BTC, UMC and NIB (Gruden et al. 2012).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Glioma patients treated with surgical resection of the tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* malignant glioma = glioblastoma (WHO IV) patients\n\nExclusion Criteria:\n\n* pregnancy\n* metastases'}, 'identificationModule': {'nctId': 'NCT01525459', 'briefTitle': 'Gene Expression, Immunological Status and Metabolome in Glioma Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Biology, Slovenia'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MNC-Glioma-1-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glioma patients', 'interventionNames': ['Procedure: Glioma resection', 'Other: Blood sampling']}], 'interventions': [{'name': 'Glioma resection', 'type': 'PROCEDURE', 'description': 'Patients will be treated with the standard surgical therapy - glioma resection.', 'armGroupLabels': ['Glioma patients']}, {'name': 'Blood sampling', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Glioma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Primož Rožman, MD, PhD', 'role': 'CONTACT', 'email': 'primoz.rozman@ztm.si', 'phone': '+386-1-5438-100'}, {'name': 'Matija Veber, dipl. biotech.', 'role': 'CONTACT', 'email': 'matija.veber@ztm.si', 'phone': '+386-51-649-350'}, {'name': 'Primož Rožman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Blood Transfusion Centre of Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Marjan Koršič, MD, PhD', 'role': 'CONTACT'}, {'name': 'Marjan Koršič, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurosurgery, University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Tamara Lah Turnšek, PhD', 'role': 'CONTACT', 'email': 'tamara.lah@nib.si', 'phone': '+386-59-23-27-03'}, {'name': 'Kristina Gruden, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institute of Biology', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Tamara Lah Turnšek, PhD', 'role': 'CONTACT', 'email': 'tamara.lah@nib.si', 'phone': '+386-59-23-27-03'}], 'overallOfficials': [{'name': 'Tamara Lah Turnšek, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Biology, Ljubljana, Slovenia'}, {'name': 'Kristina Gruden, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Biology, Ljubljana, Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Biology, Slovenia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Blood Transfusion Centre of Slovenia', 'class': 'OTHER_GOV'}, {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the National Institute of Biology, Slovenia', 'investigatorFullName': 'Tamara Lah Turnsek', 'investigatorAffiliation': 'National Institute of Biology, Slovenia'}}}}