Biomarkers for Prognosis of Glioblastoma (GBM)

NCT01493219 | Completed

• 1 other identifier: 0369-11-FB
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

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

Conditions

Glioblastoma

Keywords

Glioblastoma; Glioblastoma Multiforme; Astrocytoma; Gliosarcoma; Glioma WHO grade IV

Outcome Measures

Primary Outcomes (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)

  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.

  Up to 3 years

Study Arms (2)

Epilepsy

Blood and urine sample collection, pre and post op

Glioma

Blood and urine sample collection, pre and post op

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood, Urine, and Tissue.

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Gliosarcoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nicole A Shonka, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: September 20, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

US (1)