Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

NCT03403803 | Terminated FDA Device

• 1 other identifier: 160280
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioblastoma

Keywords

Glioblastoma; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control Group

Optune Only

Device: Optune

Optune and TMZ

Device: Optune

Interventions

Optune 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.

Also known as: TMZ

Optune Only; Optune and TMZ

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and CSF (cerebrospinal fluid)

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ekokobe Fonkem, MD

  Baylor Scott and White Medical Center, Temple, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: January 19, 2018
• Study Start: September 1, 2017
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)