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A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas: The Glioma Molecular Diagnostic Initiative


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Open (Enrolling)
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Glioma

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Trial Information

A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas: The Glioma Molecular Diagnostic Initiative


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.

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Teri N Kreisl, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

020140

NCT ID:

NCT00031538

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Glioma
  • Brain Tumor
  • Genes
  • DNA
  • Tissue
  • Classification
  • Glioma
  • Intraoperative
  • Gliomas
  • Brain Neoplasms
  • Glioma

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541