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Genetic Analysis of Brain Tumors

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00031538
Enrollment
674
Registered
2002-03-07
Start date
2002-03-01
Completion date
2015-04-29
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaplastic Astrocytoma, Astrocytoma, Glioblastoma Multiforme, Glioma, Oligodendroglioma

Keywords

Brain Tumor, Surgery, Molecular, Glioma, Intraoperative, Gliomas

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.

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 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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To generate a large publicly accessible molecular and genetic data base with prospective corollary clinical data for 1000 gliomasOngoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026