Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059020
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-04-16
Brief Title:
The Role of Gene Changes in Brain Tumor Formation and Growth
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
EGF Polymorphisms and Gliomagenesis
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine tissue from gliomas a type of brain tumor removed during surgery for gene mutations or changes thought to be involved in tumor formation and growth One common gene mutation causes the receptor for a protein called epidermal growth factor EGF to be in an active state all of the time allowing uncontrolled cell growth that can lead to tumor formation This study will analyze blood and tumor tissue samples from patients with gliomas for
Changes in the EGF gene in the tumor
Changes in other genes such as that for the EGF receptor EGFR
Changes in levels of EGF and EGFR and in other proteins and genes that respond to changes in the levels of these proteins in the tumor
Changes in the EGF gene and protein in the blood
The study will also determine if production of EGF and EGFR obtained from glioma and from blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in culture
Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment may be eligible for this study
Participants will be admitted to the NIH Clinical Center for about 3 to 10 days They will have a physical and neurological examination blood and urine tests other tests if medically necessary and will be evaluated and prepared for surgery During surgery as much of the tumor as possible will be removed A small amount of the tumor tissue will be collected for this study No tissue will be removed for this study that would not otherwise have been removed Some of the tissue will be used to culture glioma cells and the rest will be frozen and stored for examination as described above If any normal-appearing brain tissue is removed during surgery in order to enhance safety in removing the tumor the normal tissue will be studied as well Brain tissue that appears normal will not be removed strictly for research
During surgery and the day after surgery a blood sample will be drawn from a catheter plastic tube that was placed in an artery or vein for surgery If catheters are no longer in place blood will be drawn through a needle in a vein
Changes in the EGF gene in the tumor
Changes in other genes such as that for the EGF receptor EGFR
Changes in levels of EGF and EGFR and in other proteins and genes that respond to changes in the levels of these proteins in the tumor
Changes in the EGF gene and protein in the blood
The study will also determine if production of EGF and EGFR obtained from glioma and from blood cells derived from the tumor can be altered in the laboratory to grow indefinitely in culture
Patients between 18 and 75 years of age with a brain tumor that requires surgical treatment may be eligible for this study
Participants will be admitted to the NIH Clinical Center for about 3 to 10 days They will have a physical and neurological examination blood and urine tests other tests if medically necessary and will be evaluated and prepared for surgery During surgery as much of the tumor as possible will be removed A small amount of the tumor tissue will be collected for this study No tissue will be removed for this study that would not otherwise have been removed Some of the tissue will be used to culture glioma cells and the rest will be frozen and stored for examination as described above If any normal-appearing brain tissue is removed during surgery in order to enhance safety in removing the tumor the normal tissue will be studied as well Brain tissue that appears normal will not be removed strictly for research
During surgery and the day after surgery a blood sample will be drawn from a catheter plastic tube that was placed in an artery or vein for surgery If catheters are no longer in place blood will be drawn through a needle in a vein
Detailed Description:
The epidermal growth factor EGF is an important biological mediator of normal growth and repair and is critical to epithelial tissue development and maturation of the central nervous system among other functions EGF is a natural focus of interest in cancer research because of its influence over mitogenesis proliferation and tumorigenesis In addition unregulated expression of its receptor EGFR has been identified as a common event in neoplastic transformation In patients with the most malignant primary tumor of the brain the glioblastoma multiforme GBM alterations in the EGFR or in its expression levels have been identified in approximately 50 of patients We postulate that EGF-EGFR interactions may be important for the development progression and prognosis of human gliomas and that alterations of the EGF gene may predict the potential for glioma progression and the severity of disease
Patients suspected of having or with prior biopsy proof of a WHO grade II-IV central nervous system CNS glial tumors seen in the Surgical Neurology Branch NINDS will be considered for entry into this study Tissue samples of tumor resected as part of standard care will be collected at surgery and preserved for research Blood samples will also be collected Blood will also be collected from anonymous normal volunteers who donate blood at the NIH Blood Bank these anonymous donors will serve as controls
Patients suspected of having or with prior biopsy proof of a WHO grade II-IV central nervous system CNS glial tumors seen in the Surgical Neurology Branch NINDS will be considered for entry into this study Tissue samples of tumor resected as part of standard care will be collected at surgery and preserved for research Blood samples will also be collected Blood will also be collected from anonymous normal volunteers who donate blood at the NIH Blood Bank these anonymous donors will serve as controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0160 | None | None | None |