Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

NCT ID: NCT03403803

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-03-25

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.

Conditions

Glioblastoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group

No interventions assigned to this group

Optune Only

Optune

Intervention Type: 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.

Optune and TMZ

Optune

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TMZ

Eligibility 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekokobe Fonkem, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Medical Center, Temple, TX

Locations

Baylor Scott and White Medical Center

Temple, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: Main Consent

View Document

Document Type: Informed Consent Form: Control Consent

View Document

Other Identifiers

160280

Identifier Type: -

Identifier Source: org_study_id