Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT03403803
Status:
TERMINATED
Last Update Posted:
2019-03-27
First Post:
2017-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-07', 'size': 423869, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-11-09T12:57', 'hasProtocol': True}, {'date': '2017-03-09', 'size': 424714, 'label': 'Informed Consent Form: Main Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-11-09T12:57', 'hasProtocol': False}, {'date': '2017-03-09', 'size': 277575, 'label': 'Informed Consent Form: Control Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-11-09T12:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, saliva and CSF (cerebrospinal fluid)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Were not able to meet enrollment goal due to inclusion/exclusion criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2017-11-09', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva', 'timeFrame': '2 years', 'description': 'Currently, Glioblastoma is only diagnosed and monitored with brain scans. Expression levels of CD44 along with CD133, ABCC3, TNFRSF1A, AKT1, IDH2 and MGMT in samples of CSF, blood and saliva from patients receiving different types of treatment and comparing them with non-GBM patients (control group) will be tested.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Glioblastoma', 'Brain Tumor'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM).', 'detailedDescription': 'The objective of this proposed study is to determine the expression levels of a panel of markers including CD133, CD44, ABCC3, TNFRSF1A, AKT1, IDH2, and MGMT in GBM tissues and the CSF, blood, and saliva from patients with GBM receiving different types of treatment (Optune only or Optune with TMZ) and the non-brain tumor patients (controls). Our aims are: 1) To compare the differences of CD44 between the control group and the combined cancer groups at baseline; and 2) To compare the levels of CD44 and other markers among the 3 different groups such as control vs. GBM patients and Optune vs. Optune + TMZ after 8 weeks of treatment. Exploratory analysis of all other markers will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 22 years old\n* Control Group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture)\n* Non-Control Group - Diagnosed with GBM (Glioblastoma)\n\nExclusion Criteria:\n\n* Pregnancy\n* Infectious Disease to include cold, flu, HIV, etc.\n* Blood Disorder (example:low platelets, anemia, thrombosis)\n* Vascular Malformations'}, 'identificationModule': {'nctId': 'NCT03403803', 'briefTitle': 'Prognosis and Therapeutic Biomarkers for Glioblastoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Prognosis and Therapeutic Biomarkers for Glioblastoma Patients', 'orgStudyIdInfo': {'id': '160280'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group'}, {'label': 'Optune Only', 'interventionNames': ['Device: Optune']}, {'label': 'Optune and TMZ', 'interventionNames': ['Device: Optune']}], 'interventions': [{'name': 'Optune', 'type': 'DEVICE', 'otherNames': ['TMZ'], 'description': 'Optune is a wearable and portable, FDA-approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of your brain where your GBM (Glioblastoma) tumor is located.\n\nTMZ (Temozolomide) is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; as a second-line treatment for astrocytoma and a first-line treatment for glioblastoma multiforme.', 'armGroupLabels': ['Optune Only', 'Optune and TMZ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White Medical Center', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Ekokobe Fonkem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Scott and White Medical Center, Temple, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}