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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glioblastoma Multiforme, Healthy Volunteers

Intervention / Treatment
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* Other: GBM Patients
* Other: Normal Controls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Prospective Isolation of GBM Tumor Cells in GBM Patient Blood. | Circulating tumor cells will be isolated from blood drawn from GBM patients. | 3 Years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBM, Brain Tumor, Brain Neoplasm, Control, Normal Control, Volunteer