Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031538
Status:
TERMINATED
Last Update Posted:
2019-12-09
First Post:
2002-03-06
Brief Title:
Genetic Analysis of Brain Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas The Glioma Molecular Diagnostic Initiative
Status:
TERMINATED
Status Verified Date:
2015-04-29
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 analyze tissue and blood samples from patients with gliomas a type of brain tumor to develop a new classification system for these tumors Tumor classification can help guide treatment in part by predicting how aggressive a tumor may be Gliomas are currently classified according to their grade how quickly they may grow and the type of cells they are composed of This system however is not always accurate and sometimes two tumors that appear to be identical under the microscope will have very different growth patterns and responses to treatment The new classification system is based on tumor genes and proteins and may be used in the future to better predict a given tumor s behavior and response to therapy
Patients with evidence of a primary brain tumor and patients with a known glioma who will be undergoing surgery to remove the tumor may participate in this study
A sample of tumor tissue removed in the course of a participant s normal clinical care will be used in this study for laboratory analysis of genes and chromosome abnormalities A small blood sample will also be collected for genetic analysis In addition clinical information on patients condition and response to treatment will be collected every 6 months over several years This information will include findings from physical and neurologic examinations radiographic findings and response to therapy including surgery radiation and chemotherapy
Patients with evidence of a primary brain tumor and patients with a known glioma who will be undergoing surgery to remove the tumor may participate in this study
A sample of tumor tissue removed in the course of a participant s normal clinical care will be used in this study for laboratory analysis of genes and chromosome abnormalities A small blood sample will also be collected for genetic analysis In addition clinical information on patients condition and response to treatment will be collected every 6 months over several years This information will include findings from physical and neurologic examinations radiographic findings and response to therapy including surgery radiation and chemotherapy
Detailed Description:
Background
Primary brain tumors are an increasingly important cause of cancer-related morbidity and mortality in this country Little progress has been made in the treatment of patients with gliomas over the last decade One of the largest problems in our understanding and ultimately in our successful treatment of gliomas is the great heterogeneity between tumors
Objective
The purpose of this study is to generate a large publicly accessible molecular and genetic database with prospective corollary clinical data for 1000 gliomas for the purpose of allowing investigators from around the world to ask important questions regarding the pathogenesis of these tumors the development of novel molecular classification schemas and the identification of potentially new and important therapeutic targets
To substantially enlarge the growing glioma genomic and corollary clinical database currently being generated by the Glioma Molecular Diagnostic Initiative GMDI and recorded in the Repository of Malignant Brain Tumor Database REMBRANDT through the accrual of any potential glioma patient with banked formalin-fixed paraffin-embedded FFPE tissue blocks rather than restricting accrual to only those patients undergoing surgical resection of their tumor NCI Only
Cell lines will be created using glioma tissue harvested during surgery The cell lines will be used for research in the NOB laboratory as well as to advance the public s scientific knowledge by making them available to intramural extramural and private sector investigators for their own research This would be done after executing a Material Transfer Agreement MTA as needed on a case by case basis The PI of this study should be contacted directly for initiation of a cell line transfer to another organization or investigator NCI Only
Eligibility
Any patient with radiographic suggestion of a primary glial neoplasm or any patient with a known glial neoplasm
Medically indicated diagnostic andor therapeutic tumor resection or biopsy
Design
All attempts will be made to obtain specimens immediately adjacent to the areas of resection taken for permanent sections in order to optimize the likelihood that the tumor seen on permanent sections is representative of that taken for genetic analysis
Once tumor specimens have been acquired they will be immediately brought to a liquid nitrogen celltissue storage container -70-80 degrees C or -20 degrees C freezer in order of preference for storage
Following storage of the specimens the NCI-based study specimen coordinator will be contacted for determination of when frozen specimens will be sent to the NCI for analysis
10 ml of whole blood will be obtained for analysis of SNP Analogs
Patients will be evaluated every 6 months at a minimum
A total of 1000 patients will be enrolled
Primary brain tumors are an increasingly important cause of cancer-related morbidity and mortality in this country Little progress has been made in the treatment of patients with gliomas over the last decade One of the largest problems in our understanding and ultimately in our successful treatment of gliomas is the great heterogeneity between tumors
Objective
The purpose of this study is to generate a large publicly accessible molecular and genetic database with prospective corollary clinical data for 1000 gliomas for the purpose of allowing investigators from around the world to ask important questions regarding the pathogenesis of these tumors the development of novel molecular classification schemas and the identification of potentially new and important therapeutic targets
To substantially enlarge the growing glioma genomic and corollary clinical database currently being generated by the Glioma Molecular Diagnostic Initiative GMDI and recorded in the Repository of Malignant Brain Tumor Database REMBRANDT through the accrual of any potential glioma patient with banked formalin-fixed paraffin-embedded FFPE tissue blocks rather than restricting accrual to only those patients undergoing surgical resection of their tumor NCI Only
Cell lines will be created using glioma tissue harvested during surgery The cell lines will be used for research in the NOB laboratory as well as to advance the public s scientific knowledge by making them available to intramural extramural and private sector investigators for their own research This would be done after executing a Material Transfer Agreement MTA as needed on a case by case basis The PI of this study should be contacted directly for initiation of a cell line transfer to another organization or investigator NCI Only
Eligibility
Any patient with radiographic suggestion of a primary glial neoplasm or any patient with a known glial neoplasm
Medically indicated diagnostic andor therapeutic tumor resection or biopsy
Design
All attempts will be made to obtain specimens immediately adjacent to the areas of resection taken for permanent sections in order to optimize the likelihood that the tumor seen on permanent sections is representative of that taken for genetic analysis
Once tumor specimens have been acquired they will be immediately brought to a liquid nitrogen celltissue storage container -70-80 degrees C or -20 degrees C freezer in order of preference for storage
Following storage of the specimens the NCI-based study specimen coordinator will be contacted for determination of when frozen specimens will be sent to the NCI for analysis
10 ml of whole blood will be obtained for analysis of SNP Analogs
Patients will be evaluated every 6 months at a minimum
A total of 1000 patients will be enrolled
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 |
|---|---|---|---|
| 02-C-0140 | None | None | None |