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Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03403803
Recruitment Status : Terminated (Were not able to meet enrollment goal due to inclusion/exclusion criteria)
First Posted : January 19, 2018
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
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).

Condition or disease Intervention/treatment
Glioblastoma Device: Optune

Detailed Description:
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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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 25, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Group
Optune Only Device: Optune

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.

Other Name: TMZ

Optune and TMZ Device: Optune

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.

Other Name: TMZ




Primary Outcome Measures :
  1. Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva [ Time Frame: 2 years ]
    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.


Biospecimen Retention:   Samples With DNA
Blood, saliva and CSF (cerebrospinal fluid)


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.
Criteria

Inclusion Criteria:

  • 22 years old
  • Control Group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture)
  • Non-Control Group - Diagnosed with GBM (Glioblastoma)

Exclusion Criteria:

  • Pregnancy
  • Infectious Disease to include cold, flu, HIV, etc.
  • Blood Disorder (example:low platelets, anemia, thrombosis)
  • Vascular Malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403803


Locations
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United States, Texas
Baylor Scott and White Medical Center
Temple, Texas, United States, 76508
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Ekokobe Fonkem, MD Baylor Scott and White Medical Center, Temple, TX
  Study Documents (Full-Text)

Documents provided by Baylor Research Institute:
Study Protocol  [PDF] March 7, 2017
Informed Consent Form: Main Consent  [PDF] March 9, 2017

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03403803    
Other Study ID Numbers: 160280
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Baylor Research Institute:
Glioblastoma
Brain Tumor
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue