Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009035
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2001-01-23
Brief Title:
Natural History of Patients With Brain and Spinal Cord Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Natural History of Patients With Tumors of the Central Nervous System
Status:
COMPLETED
Status Verified Date:
2018-09-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study offers evaluation of patients with brain and spinal cord tumors Its purpose is threefold 1 to allow physicians in NIH s Neuro-Oncology Branch to increase their knowledge of the course of central nervous system tumors and identify areas that need further research 2 to inform participants of new studies at the National Cancer Institute and other centers as they are developed and 3 to provide patients consultation on possible treatment options
Children at least 1 year old and adults with primary malignant brain and spinal cord tumors may be eligible for this study Participants will have a medical history physical and neurological examinations and routine blood tests They may also undergo one or more of the following procedures
Magnetic resonance imaging MRI MRI is a diagnostic tool that uses a strong magnetic field and radio waves instead of X-rays to show detailed changes in brain structure and chemistry For the procedure the patient lies on a table in a narrow cylinder containing a magnetic field A contrast material called gadolinium may be used injected into a vein to enhance the images The procedure takes about an hour and the patient can speak with a staff member via an intercom system at all times
Computed axial tomography CAT or CT CT is a specialized form of X-ray imaging that produces 3-dimensional images of the brain in sections The scanner is a ring device that surrounds the patient and contains a moveable X-ray source The scan takes about 30 minutes and may be done with or without the use of a contrast dye
Positron emission tomography PET PET is a diagnostic test that is based on differences in how cells take up and use glucose sugar one of the body s main fuels The patient is given an injection of radioactive glucose A special camera surrounding the patient detects the radiation emitted by the radioactive material and produces images that show how much glucose is being used by various tissues Fast-growing cells such as tumors take up and use more glucose than normal cells do and therefore the scan might indicate the overall activity or aggressiveness of the tumor The procedure takes about an hour
When all the tests are completed the physician will discuss the results and potential treatment options with the patient Follow-up will vary according to the individual Some patients may end the study with just one visit to NIH while others may be followed at NIH regularly in conjunction with their local physicians Patients with aggressive tumors may be seen every 3 or 4 months while those with less active tumors may be seen every 6 to 12 months Permission may be requested for telephone follow-up with the patient or physician of patients not seen regularly at NIH
Children at least 1 year old and adults with primary malignant brain and spinal cord tumors may be eligible for this study Participants will have a medical history physical and neurological examinations and routine blood tests They may also undergo one or more of the following procedures
Magnetic resonance imaging MRI MRI is a diagnostic tool that uses a strong magnetic field and radio waves instead of X-rays to show detailed changes in brain structure and chemistry For the procedure the patient lies on a table in a narrow cylinder containing a magnetic field A contrast material called gadolinium may be used injected into a vein to enhance the images The procedure takes about an hour and the patient can speak with a staff member via an intercom system at all times
Computed axial tomography CAT or CT CT is a specialized form of X-ray imaging that produces 3-dimensional images of the brain in sections The scanner is a ring device that surrounds the patient and contains a moveable X-ray source The scan takes about 30 minutes and may be done with or without the use of a contrast dye
Positron emission tomography PET PET is a diagnostic test that is based on differences in how cells take up and use glucose sugar one of the body s main fuels The patient is given an injection of radioactive glucose A special camera surrounding the patient detects the radiation emitted by the radioactive material and produces images that show how much glucose is being used by various tissues Fast-growing cells such as tumors take up and use more glucose than normal cells do and therefore the scan might indicate the overall activity or aggressiveness of the tumor The procedure takes about an hour
When all the tests are completed the physician will discuss the results and potential treatment options with the patient Follow-up will vary according to the individual Some patients may end the study with just one visit to NIH while others may be followed at NIH regularly in conjunction with their local physicians Patients with aggressive tumors may be seen every 3 or 4 months while those with less active tumors may be seen every 6 to 12 months Permission may be requested for telephone follow-up with the patient or physician of patients not seen regularly at NIH
Detailed Description:
Background
This protocol is designed to evaluate patients with tumors of the central nervous system CNS who appear to be probable candidates for future protocol entry or have disease manifestations that are of unique scientific interest importance andor educational value
Objective
To evaluate patients with tumors of the central nervous system CNS who are probable future candidates for NCI Phase I and II protocols
To follow patients with tumors of the CNS that are representative of important scientific andor clinical principles
To allow a steady flow of patients with tumors of the CNS at the NIH for the purpose of educating nurses medical students residents clinical fellows and physicians in the management and care of this specialized subgroup of cancer patients
Eligibility
All patients greater than 12 months of age with tumors of the CNS of interest to the NOB who may be candidates for another NOB trial at some point in the future
Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical andor scientific questions andor shed light on important aspects of the disease
Patients with tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff
Ability of subject or Legally Authorized Representative LAR to understand and the willingness to sign a written informed consent document Availability of a parent or legal guardian to give informed consent for children
Design
All patients will undergo an initial evaluation at the Clinical Center by a member of the NOB where past medical and oncologic histories will be obtained as well as relevant data such as neuroimaging and pathology review A total of 3000 patients will be accrued to this study
Patients may be seen at the NIH Clinical Center at varying intervals depending on the clinical situation but data related to the natural history of their disease course and outcome will be collected at least every six months
This protocol is designed to evaluate patients with tumors of the central nervous system CNS who appear to be probable candidates for future protocol entry or have disease manifestations that are of unique scientific interest importance andor educational value
Objective
To evaluate patients with tumors of the central nervous system CNS who are probable future candidates for NCI Phase I and II protocols
To follow patients with tumors of the CNS that are representative of important scientific andor clinical principles
To allow a steady flow of patients with tumors of the CNS at the NIH for the purpose of educating nurses medical students residents clinical fellows and physicians in the management and care of this specialized subgroup of cancer patients
Eligibility
All patients greater than 12 months of age with tumors of the CNS of interest to the NOB who may be candidates for another NOB trial at some point in the future
Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical andor scientific questions andor shed light on important aspects of the disease
Patients with tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff
Ability of subject or Legally Authorized Representative LAR to understand and the willingness to sign a written informed consent document Availability of a parent or legal guardian to give informed consent for children
Design
All patients will undergo an initial evaluation at the Clinical Center by a member of the NOB where past medical and oncologic histories will be obtained as well as relevant data such as neuroimaging and pathology review A total of 3000 patients will be accrued to this study
Patients may be seen at the NIH Clinical Center at varying intervals depending on the clinical situation but data related to the natural history of their disease course and outcome will be collected at least every six months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-C-0070 | None | None | None |