Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

Terminated

• Conditions: Glioblastoma
• Interventions: Device: Optune

• Registration Number: NCT03403803
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-19
• Status Verified: 2019-03
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optune and TMZ	Optune	-
Optune Only	Optune	-

Primary Outcome Measures

Name	Time	Method
Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva	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.

Trial Locations

Locations (1)

Baylor Scott and White Medical Center; 🇺🇸 Temple, Texas, United States