Genetic Analysis of Brain Tumors

December 6, 2019 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

674

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike
    • New York
      • New York, New York, United States, 10032-3784
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-6541
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To generate a large publicly accessible molecular and genetic data base with prospective corollary clinical data for 1000 gliomas
Time Frame: Ongoing
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

April 29, 2015

Study Registration Dates

First Submitted

March 6, 2002

First Submitted That Met QC Criteria

March 6, 2002

First Posted (Estimate)

March 7, 2002

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

April 29, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020140
  • 02-C-0140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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