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Were not able to meet enrollment goal due to inclusion/exclusion criteria
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | |||
| Optune Only |
| ||
| Optune and TMZ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optune | Device | 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. TMZ (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva | 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.
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| Name | Affiliation | Role |
|---|---|---|
| Ekokobe Fonkem, MD | Baylor Scott and White Medical Center, Temple, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Medical Center | Temple | Texas | 76508 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2017 | Nov 9, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Main Consent | Mar 9, 2017 | Nov 9, 2017 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Control Consent | Mar 9, 2017 | Nov 9, 2017 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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Blood, saliva and CSF (cerebrospinal fluid)
|
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |