GliomaNCT00985036
Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients
An observational study of Glioma and Meningioma, run by Marquette General Health System at 1 site in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glioma, Meningioma
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presenting to Marquette General Hospital with a probable or confirmed diagnosis of meningioma or glioma
Who may be able to join
- any patient presenting with glioma or meningioma
Who cannot join
- a different type of brain tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Marquette General Hospital
Marquette, Michigan, 49855
About this study
Official title: 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?
- Conditions
- Glioma, Meningioma
- Being tested
- Blood test
- Keywords
- glioma, meningioma, VEGF
- Medical subject headings
- Glioma, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Glioma | patients who are diagnosed with and are being treated for glioma Receives: Procedure: Blood test | |
| meningioma | patients who are diagnosed with and are being treated for meningioma Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if VEGF levels correlate with tumor progression or recurrence
Measured: every one to three months
Secondary outcomes (3)
Determine if the VEGF level is an indicator of the response to treatment.
Measured: Every one to three months
Determine if the VEGF level correlates with tumor histology and behavior.
Measured: Every one to three months
Determine if there is a relationship between VEGF level and outcome.
Measured: Every one to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette General Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Upper Michigan Brain Tumor Center
- Responsible party
- Principal investigator, Richard A. Rovin, MD FACS, Marquette General Health System
- Investigators
- Richard A Rovin, MD, FACS, Principal investigator, Upper Michigan Brain Tumor CenterRobert J Winn, PhD, Principal investigator, Northern Michigan UniversitySuresh Nukala, MD, Principal investigator, Marquette General Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985036
- Sponsor's protocol ID
- MGH-VEGF-1
- Status last verified
- Apr 2012
- First submitted
- 25 Sep 2009
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is VEGF a Useful Serum Biomarker for Patients Diagnosed With Meningioma or Glioma?
- ClinicalTrials.gov ID
- NCT00985036
- Acronym / sponsor ID
- MGH-VEGF-1
- Conditions
- Glioma, Meningioma
- Keywords
- glioma, meningioma, VEGF
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marquette General Health SystemUniversity, hospital or other
- Collaborators
- Upper Michigan Brain Tumor Center
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glioma | – | Procedure: Blood testpatients who are diagnosed with and are being treated for glioma |
| meningioma | – | Procedure: Blood testpatients who are diagnosed with and are being treated for meningioma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to Marquette General Hospital with a probable or confirmed diagnosis of meningioma or glioma
Key inclusion criteria (1 listed)
- any patient presenting with glioma or meningioma
Key exclusion criteria (1 listed)
- a different type of brain tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testan 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 | Procedure or surgery | Glioma, meningioma |
Primary outcome
Determine if VEGF levels correlate with tumor progression or recurrence
Time frame: every one to three months
3 secondary outcomes
Determine if the VEGF level is an indicator of the response to treatment.
Time frame: Every one to three months
Determine if the VEGF level correlates with tumor histology and behavior.
Time frame: Every one to three months
Determine if there is a relationship between VEGF level and outcome.
Time frame: Every one to three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Rovin, MD, FACS principal investigator
Upper Michigan Brain Tumor Center
Robert J Winn, PhD principal investigator
Northern Michigan University
Suresh Nukala, MD principal investigator
Marquette General Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Meningioma, run by Marquette General Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if VEGF levels correlate with tumor progression or recurrence (time frame: every one to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.