Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

Glioblastoma Clinical Trial

Official title:

Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03403803
• Other study ID #: 160280
• Status: Terminated
• Start date: September 1, 2017
• Est. completion date: March 25, 2019

Study information

• Verified date: March 2019
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor Scott and White Medical Center	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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