NCT00985036

Brief 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. 1.Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?
  2. 2.Is the VEGF level an indicator of the response to treatment?
  3. 3.Does the VEGF level correlate with tumor histology and behavior?
  4. 4.Is there a relationship between VEGF level and outcome?

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

September 25, 2009

Last Update Submit

April 20, 2012

Conditions

Keywords

gliomameningiomaVEGF

Outcome Measures

Primary Outcomes (1)

  • Determine if VEGF levels correlate with tumor progression or recurrence

    every one to three months

Secondary Outcomes (3)

  • Determine if the VEGF level is an indicator of the response to treatment.

    Every one to three months

  • Determine if the VEGF level correlates with tumor histology and behavior.

    Every one to three months

  • Determine if there is a relationship between VEGF level and outcome.

    Every one to three months

Study Arms (2)

Glioma

patients who are diagnosed with and are being treated for glioma

Procedure: Blood test

meningioma

patients who are diagnosed with and are being treated for meningioma

Procedure: Blood test

Interventions

Blood testPROCEDURE

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

Gliomameningioma

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to Marquette General Hospital with a probable or confirmed diagnosis of meningioma or glioma

You may qualify if:

  • any patient presenting with glioma or meningioma

You may not qualify if:

  • a different type of brain tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

GliomaMeningioma

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations