Status:
COMPLETED
Biomarkers for Prognosis of Glioblastoma (GBM)
Lead Sponsor:
University of Nebraska
Conditions:
Glioblastoma
Eligibility:
All Genders
19+ years
Brief Summary
The purpose of this study is: 1. To learn if (MMP-2, MMP-9 and NGAL) which are substances found in blood and urine associated with tumors, can be used as tumor markers in the management and treatment...
Detailed Description
Matrix metalloproteinases (MMP) -2 and -9 belong to a multigene family of degradative enzymes implicated in the neoangiogenesis required for tumor growth. In the central nervous system (CNS), MMP-2, M...
Eligibility Criteria
Inclusion
- Subjects scheduled for a surgical excision or biopsy as ordered by his/her clinic or inpatient physician for epilepsy OR subjects newly diagnosed with high grade (grade IV) glioma (The performance of this procedure will be under standard of care surgical guidelines.)
- non-tumor tissue controls from subjects undergoing surgery for epilepsy
- tumor tissue from subjects undergoing surgery for grade IV glioma
- Epilepsy subject identified as a control undergoing surgery must willingly provide pre-op and post-op serum and urine samples for research
- GMB subject must willingly provide blood and urine samples pre-op and post-op as well as blood and urine samples for research and QOL measurements taken at protocol specific time points
- GBM subject plans to receive clinical care visits which coincide with MRIs and/or with a change in symptoms and any secondary surgical resections and/or biopsies solely at UNMC/TNMC
- Subjects must willingly give signed informed consent
- Age 19 years or older (the age of consent in Nebraska)
- Women must not be pregnant due to teratogenic effects of MRI
Exclusion
- Inability to fulfill the requirements of the protocol
- No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
- Known to be positive for HIV or infectious hepatitis, type A, B or C or active Hepatitis
- Subjects newly diagnosed with high grade (grade IV) glioma (GBM) unable to be followed by MRI due to
- Pacemaker
- Chronic kidney disease stage 3-5 (Glomerular Filtration Rate \<60)
- Unable to lay flat for 90 minutes
- Any metallic foreign body not approved for MRI
- Known hypersensitivity to Gadolinium contrast or other required for MRI
Key Trial Info
Start Date :
September 20 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01493219
Start Date
September 20 2011
End Date
September 1 2017
Last Update
September 14 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198