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Completed

NCT Number: NCT01135875

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

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

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GBM Patients

Other

2 teaspoons of blood will be collected during select clinic visits.

Normal Controls

Other

2 teaspoons of blood will be collected once.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 3, 2010
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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