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Natural History Study of Patients With Central Nervous System Tumors Being Evaluated at the National Institutes of Health

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00458640
  Purpose

RATIONALE: Gathering information about patients with central nervous system tumors over time may help doctors learn more about the disease and find better methods of treatment and on-going care.

PURPOSE: This natural history study is collecting disease-related health information over time from patients with central nervous system tumors being evaluated at the National Institutes of Health.


Condition Intervention
Brain and Central Nervous System Tumors
Chordoma
Neuroblastoma
Procedure: physiologic testing

MedlinePlus related topics:   Cancer    Neuroblastoma   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Evaluation of the Natural History of Patients With Tumors of the Central Nervous System

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Evaluation of patients with CNS tumors who are probable future candidates for NCI phase I and II protocols
  • Follow patients with CNS tumors that are representative of important scientific and/or clinical principles
  • Attain a steady flow of patients with CNS tumors at the NIH, which will help to educate nurses, medical residents, clinical fellows, and others in management and care of this subgroup of cancer patients

Estimated Enrollment:   3000
Study Start Date:   January 2001
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Evaluate patients with CNS tumors who are probable future candidates for NCI phase I and II protocols.
  • Follow patients with CNS tumors that are representative of important scientific and/or clinical principles.
  • Attain a steady flow of patients with CNS tumors at the NIH, which will help to educate nurses, medical residents, clinical fellows, and others in management and care of this subgroup of cancer patients.

OUTLINE: Patients receive an initial evaluation by the NCI Neuro-Oncology Branch at the NIH Clinical Center. Patients may choose to end their participation on the study after the initial evaluation or may continue being evaluated at NIH. Generally, patients living in close proximity to the NIH are followed at NIH every 3-6 months. Patients living at a distance from NIH resume standard care with their local physician, but either they are followed periodically at NIH (e.g., if disease progression occurs) or they (and/or their physician) are contacted by the Neuro-Oncology Branch at least every 6 months to generally follow the natural history of the disease and patient outcome.

Patients may undergo any or all of the following procedures at initial or follow-up evaluations: MRI or CT scan, PET scan, blood tests, neurologic exam, and physical exam and history.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Patients with CNS tumors who meet any of the following criteria:

    • Potential candidate for a future NIH Neuro-Oncology Branch (NOB) protocol
    • Tumor is of particular interest to the NOB because it poses important clinical and/or scientific questions or sheds light on important aspects of the disease
    • Tumor would offer an important educational benefit to neuro-oncology trainees and staff
  • Must not be immediately eligible for another ongoing NOB protocol

PATIENT CHARACTERISTICS:

Age

  • 12 months and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458640

Locations
United States, Maryland
NCI - Neuro-Oncology Branch     Recruiting
      Bethesda, Maryland, United States, 20892-8200
      Contact: Patient Recruitment     301-402-6298        
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office     Recruiting
      Bethesda, Maryland, United States, 20892
      Contact: Patient Recruitment     888-NCI-1937        

Sponsors and Collaborators

Investigators
Study Chair:     Howard A. Fine, MD     NCI - Neuro-Oncology Branch    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 
Web site for additional information  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000078676, NCI-01-C-0070
First Received:   April 9, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00458640
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma  
adult anaplastic meningioma  
adult anaplastic oligodendroglioma  
adult brain stem glioma  
adult craniopharyngioma  
adult diffuse astrocytoma  
adult ependymoblastoma  
adult ependymoma  
adult giant cell glioblastoma  
adult medulloblastoma  
adult meningeal hemangiopericytoma  
adult myxopapillary ependymoma  
adult oligodendroglioma  
adult papillary meningioma  
adult pilocytic astrocytoma  
adult pineoblastoma
adult pineocytoma
adult subependymoma
adult ependymoma
adult gliosarcoma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult supratentorial primitive neuroectodermal tumor (PNET)
adult melanocytic lesion
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
mixed gliomas
recurrent adult brain tumor
childhood central nervous system germ cell tumor

Study placed in the following topic categories:
Glioblastoma
Choroid Plexus Neoplasms
Neuroectodermal Tumors, Primitive
Central Nervous System Neoplasms
Chordoma
Neuroblastoma
Ependymoma
Neoplasms, Germ Cell and Embryonal
Craniopharyngioma
Neuroepithelioma
Meningioma
Glioma
Choroid Plexus neoplasms
Nervous System Neoplasms
Spinal cord neoplasm
Astrocytoma
Hemangiopericytoma
Recurrence
Neuroectodermal Tumors
Brain Neoplasms
Medulloblastoma
Spinal Cord Neoplasms
Oligodendroglioma
Gliosarcoma
Pinealoma
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on August 21, 2008




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