Genetic Analysis of Brain Tumors
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 1 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | March 1, 2002 |
| End Date: | April 29, 2015 |
A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas: The Glioma Molecular Diagnostic Initiative
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.
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.
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 and/or 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 cell/tissue 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 and/or 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 cell/tissue 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.
- ELIGIBILITY CRITERIA:
Any patient with radiographic suggestion of a primary glial neoplasm or any patient with a
known glial neoplasm.
Medically indicated (diagnostic and/or therapeutic) tumor resection, or biopsy.
Informed consent from patient or parents of children under the age of 18 years old.
Patients or parents of children under the age of 18 must sign an authorization for the
release of their protected health information.
We found this trial at
3
sites
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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