- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985036
Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients
April 20, 2012 updated by: Richard A. Rovin, MD FACS, Marquette General Health System
Is VEGF a Useful Serum Biomarker for Patients Diagnosed With Meningioma or Glioma?
Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF) circulating in the blood stream of patients diagnosed with either a meningioma or a glioma. The questions that will be addressed include:
- Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?
- Is the VEGF level an indicator of the response to treatment?
- Does the VEGF level correlate with tumor histology and behavior?
- Is there a relationship between VEGF level and outcome?
Study Overview
Study Type
Observational
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
-
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Michigan
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Marquette, Michigan, United States, 49855
- Marquette General Hospital
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-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients presenting to Marquette General Hospital with a probable or confirmed diagnosis of meningioma or glioma
Description
Inclusion Criteria:
- any patient presenting with glioma or meningioma
Exclusion Criteria:
- a different type of brain tumor
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 |
|---|---|
|
Glioma
patients who are diagnosed with and are being treated for glioma
|
an additional vial of blood will be obtained at the time of MRI or at the time of routine blood tests ordered by the medical oncologist.
In other words, there will be no extra needle sticks.
Just an extra vial of blood will be taken during a routine blood test
|
|
meningioma
patients who are diagnosed with and are being treated for meningioma
|
an additional vial of blood will be obtained at the time of MRI or at the time of routine blood tests ordered by the medical oncologist.
In other words, there will be no extra needle sticks.
Just an extra vial of blood will be taken during a routine blood test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine if VEGF levels correlate with tumor progression or recurrence
Time Frame: every one to three months
|
every one to three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine if the VEGF level is an indicator of the response to treatment.
Time Frame: Every one to three months
|
Every one to three months
|
|
Determine if the VEGF level correlates with tumor histology and behavior.
Time Frame: Every one to three months
|
Every one to three months
|
|
Determine if there is a relationship between VEGF level and outcome.
Time Frame: Every one to three months
|
Every one to three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard A Rovin, MD, FACS, Upper Michigan Brain Tumor Center
- Principal Investigator: Robert J Winn, PhD, Northern Michigan University
- Principal Investigator: Suresh Nukala, MD, Marquette General Health Systems
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
September 1, 2009
Primary Completion (ANTICIPATED)
September 1, 2011
Study Completion (ANTICIPATED)
January 1, 2012
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 25, 2009
First Posted (ESTIMATE)
September 28, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 24, 2012
Last Update Submitted That Met QC Criteria
April 20, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Glioma
- Meningioma
Other Study ID Numbers
- MGH-VEGF-1
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.