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

Tracking Information

First Received Date ^ICMJE

April 9, 2007

Last Updated Date

June 9, 2009

Start Date ^ICMJE

January 2001

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00458640 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Brain and Central Nervous System Tumors
Chordoma
Neuroblastoma

Intervention ^ICMJE

Other: physiologic testing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00458640

Responsible Party

Study ID Numbers ^ICMJE

CDR0000078676, NCI-01-C-0070

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Howard A. Fine, MD

NCI - Neuro-Oncology Branch

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP