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Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03403803
Enrollment
10
Registered
2018-01-19
Start date
2017-09-01
Completion date
2019-03-25
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Keywords

Glioblastoma, Brain Tumor

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).

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.

Interventions

DEVICEOptune

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.

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva2 yearsCurrently, 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026