Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-26 @ 12:22 AM
Study NCT ID:
NCT03189420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2017-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glioma Microenvironment an Exploratory Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}], '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'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094463', 'term': 'Transurethral Resection of Bladder'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gene expression changes', 'timeFrame': '2 years', 'description': 'Though RNA-seq, ATAC-seg and subsequent analysis we will be able to monitor the differential gene expression through different time points followed by stimuli.'}], 'secondaryOutcomes': [{'measure': 'cytokines expression', 'timeFrame': '2 years', 'description': 'will evaluate the immunologic characteristic of the tumor through cytokines levels analysis (TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, IFN-γ, TGF-β e IL-1ra).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glioma', 'glioblastoma', 'low grade tumor'], 'conditions': ['Glioma of Brain']}, 'referencesModule': {'references': [{'pmid': '28592714', 'type': 'BACKGROUND', 'citation': 'Komori T. The 2016 WHO Classification of Tumours of the Central Nervous System: The Major Points of Revision. Neurol Med Chir (Tokyo). 2017 Jul 15;57(7):301-311. doi: 10.2176/nmc.ra.2017-0010. Epub 2017 Jun 8.'}, {'pmid': '28063055', 'type': 'BACKGROUND', 'citation': 'Galatro TF, Vainchtein ID, Brouwer N, Boddeke EWGM, Eggen BJL. Isolation of Microglia and Immune Infiltrates from Mouse and Primate Central Nervous System. Methods Mol Biol. 2017;1559:333-342. doi: 10.1007/978-1-4939-6786-5_23.'}, {'pmid': '28292436', 'type': 'BACKGROUND', 'citation': 'Quail DF, Joyce JA. The Microenvironmental Landscape of Brain Tumors. Cancer Cell. 2017 Mar 13;31(3):326-341. doi: 10.1016/j.ccell.2017.02.009.'}, {'pmid': '24878820', 'type': 'BACKGROUND', 'citation': 'Chiorean R, Berindan-Neagoe I, Braicu C, Florian IS, Leucuta D, Crisan D, Cernea V. Quantitative expression of serum biomarkers involved in angiogenesis and inflammation, in patients with glioblastoma multiforme: correlations with clinical data. Cancer Biomark. 2014;14(2-3):185-94. doi: 10.3233/CBM-130310.'}]}, 'descriptionModule': {'briefSummary': 'Diffuse glioms are primary brain tumors characterized by infiltrative growth and high heterogeneity, which render the disease mostly incurable. Advances in genetic analysis revealed that molecular and epigenetic alterations predict patients´s overall survival and clinical outcome. However, glioma tumorigenicity is not exclusively caused by its genetic alterations. The crosstalk between tumor cells and the surrounding microenvironment plays a crucial role in modulating glioma growth and aggressiveness. In this sense, to understand the tumor microenvironment would elucidate potential treatment alternatives. The focus will be to evaluate myeloid cells and cytokines levels.', 'detailedDescription': 'The proposal is to study gene expression and early epigenetic changes in myeloid cells from brain tumors and co-culture experiments. Tough RNA-seq, ATAC-seg and subsequent analysis to monitor the differential gene expression through different time points followed by stimuli. The study will compare the obtained results with sequencing data from microglia of full-fledged human tumor samples (glioblastoma and low grade gliomas). Additionally it will evaluated the immunologic characteristic of the tumor through cytokines levels analysis (TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, IFN-γ, TGF-β e IL-1ra).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged between 18-65 years old diagnosed with glioblastoma or low grade glioma', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 65 years old with brain tumor\n* Patients that will be submitted to brain tumor ressection\n\nExclusion Criteria:\n\n* Chronic neurodegenerative and inflamatory diseases'}, 'identificationModule': {'nctId': 'NCT03189420', 'briefTitle': 'Glioma Microenvironment an Exploratory Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sirio-Libanes'}, 'officialTitle': 'Glioma Microenvironment an Exploratory Study', 'orgStudyIdInfo': {'id': 'CAAE 58310716.6.0000.5461'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glioblastoma', 'description': 'Samples of brain tumor diagnosed as glioblastoma', 'interventionNames': ['Procedure: Tumor resection']}, {'label': 'Low grade glioma', 'description': 'Samples of brain tumor diagnosed as low grade glioma', 'interventionNames': ['Procedure: Tumor resection']}], 'interventions': [{'name': 'Tumor resection', 'type': 'PROCEDURE', 'otherNames': ['surgery'], 'description': 'The tumors will be resected in routine therapeutic surgeries', 'armGroupLabels': ['Glioblastoma', 'Low grade glioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01308060', 'city': 'São Paulo', 'state': 'Sao', 'country': 'Brazil', 'facility': 'Hospital Sirio Libanes', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sirio-Libanes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, PhD', 'investigatorFullName': 'Raquel Chacon Ruiz Martinez', 'investigatorAffiliation': 'Hospital Sirio-Libanes'}}}}