Genetic Analysis of Brain Tumors

NCT00031538 | Terminated

• 2 other identifiers: 02014002-C-0140
• Study Type: observational
• Target: 674
• Locations: 1 country
• Sites: 3

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.

Conditions

Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Oligodendroglioma; Astrocytoma

Keywords

Brain Tumor; Surgery; Molecular; Glioma; Intraoperative; Gliomas

Outcome Measures

Primary Outcomes (1)

• To generate a large publicly accessible molecular and genetic data base with prospective corollary clinical data for 1000 gliomas

  Ongoing

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Columbia University

New York, New York, 10032-3784, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-6541, United States

Location

Related Publications (3)

• Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, et al. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. doi: 10.1200/JCO.1993.11.5.850.

  PMID: 8487049 BACKGROUND

• Cairncross JG, Macdonald DR. Successful chemotherapy for recurrent malignant oligodendroglioma. Ann Neurol. 1988 Apr;23(4):360-4. doi: 10.1002/ana.410230408.

  PMID: 3382171 BACKGROUND

• Fine HA. The basis for current treatment recommendations for malignant gliomas. J Neurooncol. 1994;20(2):111-20. doi: 10.1007/BF01052722.

  PMID: 7807189 BACKGROUND

MeSH Terms

Conditions

Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ronald E Gress, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2002
• First Posted: March 7, 2002
• Study Start: March 1, 2002
• Study Completion: April 29, 2015
• Last Updated: December 9, 2019

Record last verified: 2015-04-29

Locations

US (3)