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

Healthy Volunteers Clinical Trial

Official title:

Human Glioblastoma Multiforme (GBM) Circulating Tumor Cells (CTCs) as Early, Less Invasive Markers of Progression and Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135875
• Other study ID #: CTC-01
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: October 15, 2013
• Start date: October 2009
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Healthy Volunteers

Intervention

Other:
• GBM Patients
2 teaspoons of blood will be collected during select clinic visits.
• Normal Controls
2 teaspoons of blood will be collected once.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Human GBM CD Antigen Signature.	Already established and stored GBM cell lines will be screened for CD antigens to confirm that a selective cell surface antigen can be identified.	3 Years	No
Secondary	Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood.	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.	3 Years	No
Secondary	Prospective Isolation of GBM Tumor Cells in GBM Patient Blood.	Circulating tumor cells will be isolated from blood drawn from GBM patients.	3 Years	No
Secondary	Prospective Evaluation of the Routine Medical History of GBM Patients.	Medical records of GBM patients will be used to determine how circulating tumor cells impact outcome.	3 Years	No