Laboratory Study of Early Tumor Markers in the Peripheral Blood of Glioblastoma Multiforme Patients

Completed

• Conditions: Glioblastoma Multiforme; Healthy Volunteers
• Interventions: Other: GBM Patients; Other: Normal Controls

• Registration Number: NCT01135875
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study is to determine if tumor cells can be detected in the blood of patients diagnosed with a brain tumor.

Detailed Description

Despite aggressive therapies, Glioblastoma Multiforme (GBM) is rapidly fatal. GBMs are increasingly recognized for occasionally metastasizing through the peripheral blood to distant locations. This research study involves the detection and novel characterization of human GBM (hGBM) circulating tumor cells (CTCs) within the peripheral blood of brain tumor patients by identifying their unique cell surface antigen profile, determining an optimal isolation protocol, and quantitatively and qualitatively reporting the yield and characteristics.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-15
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• 18 to 89 years of age
• Weight of at least 110 pounds
• Able to provide informed consent for self

Exclusion Criteria

• Patients with active malignant tumors other than GBM

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GBM Patients	GBM Patients	GBM Patients with a histologically confirmed or suspected diagnosis of glioblastoma multiforme.
Normal Controls	Normal Controls	Normal Controls will be adult volunteers who identify themselves as not having been diagnosed with a glioblastoma multiforme.

Primary Outcome Measures

Name	Time	Method
Identification of Human GBM CD Antigen Signature.	3 Years	Already established and stored GBM cell lines will be screened for CD antigens to confirm that a selective cell surface antigen can be identified.

Secondary Outcome Measures

Name	Time	Method
Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood.	3 Years	Frozen and fresh human blood will be seeded with human GBM cells from established stored GBM cell lines and subjected to antibody-based cell identification and isolation procedures.
Prospective Isolation of GBM Tumor Cells in GBM Patient Blood.	3 Years	Circulating tumor cells will be isolated from blood drawn from GBM patients.
Prospective Evaluation of the Routine Medical History of GBM Patients.	3 Years	Medical records of GBM patients will be used to determine how circulating tumor cells impact outcome.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States