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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.
Study NCT00458640.   Last updated on November 21, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Natural History Study of Patients With Central Nervous System Tumors Being Evaluated at the National Institutes of Health
Official Title † Evaluation of the Natural History of Patients With Tumors of the Central Nervous System
Brief Summary

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.
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.
Study Phase
Study Type † Observational
Study Design †
Primary Outcome Measure † 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
Secondary Outcome Measure †
Condition † Brain and Central Nervous System Tumors
Chordoma
Neuroblastoma
Intervention † Procedure: physiologic testing
MEDLINE PMIDs
Links 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
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 3000
Start Date † January 2001
Completion Date
Eligibility 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
Gender Both
Ages 1 Year and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00458640
Organization ID CDR0000078676
Secondary IDs †† NCI-01-C-0070
Study Sponsor † NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators †
Study Chair:     Howard A. Fine, MD     NCI - Neuro-Oncology Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date † April 9, 2007
Last Updated Date November 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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