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Trial record 66 of 1115 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

Biomarkers for Prognosis of Glioblastoma (GBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493219
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : January 31, 2018
Information provided by (Responsible Party):
Nicole Shonka, University of Nebraska

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 of glioblastoma.
  2. To study the relationship between MMP-2, MMP-9 and NGAL with quality of life and disease symptoms.

Condition or disease

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, MMP-9 and neutrophil gelatinase-associated lipocalin (NGAL) are overexpressed in orthotopic models and also in human brain tumor specimens. Furthermore, serum and urinary levels of these markers have been shown to correlate with the presence and status of brain tumors in all types of primary brain tumors. A major challenge in the treatment of primary brain tumors is the dependence on magnetic resonance imaging (MRI) to differentiate disease progression from treatment-related change. This is particularly challenging in glioblastomas (GBM) where multimodality therapy with radiation and chemotherapy is commonly used and can lead to pseudoprogression and treatment-related tissue necrosis, both of which can masquerade as true tumor progression. Often we are faced with the decision to treat based on imaging findings alone or to recommend that patients have another invasive surgery. We hypothesize that MMP-2, MMP-9 and NGAL will: 1) be detected on tumor tissue by immunohistochemistry and not on non-tumor (epilepsy) brain tissue, 2) parallel the course of disease in the urine and/or serum of patients and 3) remain unchanged in the event of pseudoprogression and treatment related imaging changes. Quality of life, patient symptoms, and cognitive function are vitally important in patients with GBM. Quality of life and selected symptoms will also be assessed and correlated with serum and urine biomarkers. We hope to confirm the utility of MMP-2, MMP-9 and NGAL in the management of GBM.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MMP-2, MMP-9 and NGAL as Biomarkers for Glioblastoma (GBM) Biomarkers for the Prognosis of Glioblastoma
Study Start Date : September 2011
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Blood and urine sample collection, pre and post op
Blood and urine sample collection, pre and post op

Primary Outcome Measures :
  1. 1) To provide preliminary evidence that MMP-2 and MMP-9/NGAL ratio in tissue corresponds with their presence in the urine and blood in patients undergoing surgery for epilepsy (Aim 1a) and in patients with grade IV glioma (Aim 1b) [ Time Frame: Up to 3 years ]
    For each outcome (MMP-2, MMP-9 and MMP-9/NGAL), Pearson's correlation coefficient will be used to examine the association between 1) tissue and urine and 2) tissue and blood. Spearman's correlation will be used in the event that the data are not normally distributed and a suitable transformation is not evident. Due to the anticipated interaction of group with presence of these biomarkers, these analyses will be conducted separately for epilepsy control patients and GBM patients.

Biospecimen Retention:   Samples Without DNA
Whole Blood, Urine, and Tissue.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Inclusion Criteria:

  1. 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
  2. Epilepsy subject identified as a control undergoing surgery must willingly provide pre-op and post-op serum and urine samples for research
  3. 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
  4. 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
  5. Subjects must willingly give signed informed consent
  6. Age 19 years or older (the age of consent in Nebraska)
  7. Women must not be pregnant due to teratogenic effects of MRI

Exclusion Criteria:

  1. Inability to fulfill the requirements of the protocol
  2. No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
  3. Known to be positive for HIV or infectious hepatitis, type A, B or C or active Hepatitis
  4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01493219

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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
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Principal Investigator: Nicole Shonka, MD UNMC

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Responsible Party: Nicole Shonka, Principal Investigator, University of Nebraska Identifier: NCT01493219     History of Changes
Other Study ID Numbers: 369-11
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not available
Keywords provided by Nicole Shonka, University of Nebraska:
Glioblastoma Multiforme
Glioma WHO grade IV
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue