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Genetic Analysis of Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Year - 99 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00031538
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ronald E Gress, M.D.
Principal Investigator Affiliation National Cancer Institute (NCI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Oligodendroglioma, Astrocytoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892

Columbia University, New York, New York

Status

Address

Columbia University

New York, New York, 10032-3784

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-6541