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

October 15, 2013 updated by: University of Florida

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited during routine interactions with the investigators.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GBM Patients
GBM Patients with a histologically confirmed or suspected diagnosis of glioblastoma multiforme.
Other: GBM Patients
2 teaspoons of blood will be collected during select clinic visits.
Normal Controls
Normal Controls will be adult volunteers who identify themselves as not having been diagnosed with a glioblastoma multiforme.
Other: Normal Controls
2 teaspoons of blood will be collected once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Human GBM CD Antigen Signature.
Time Frame: 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.
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood.
Time Frame: 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.
3 Years
Prospective Isolation of GBM Tumor Cells in GBM Patient Blood.
Time Frame: 3 Years
Circulating tumor cells will be isolated from blood drawn from GBM patients.
3 Years
Prospective Evaluation of the Routine Medical History of GBM Patients.
Time Frame: 3 Years
Medical records of GBM patients will be used to determine how circulating tumor cells impact outcome.
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Brent Reynolds, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

October 17, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Clinical Trials on GBM Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe