AstrocytomaNCT00009035
Natural History of Patients With Brain and Spinal Cord Tumors
An observational study of Astrocytoma and Oligodendroglioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Astrocytoma, Oligodendroglioma, Glioblastoma
- How many people
- 3,050 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2001to 11 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients greater than or equal to 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 and/or scientific questions and/or 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.
Who cannot join
- Patients less than 12 months of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Natural History of Patients With Tumors of the Central Nervous System
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:
Read more
- 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.
...
Read the 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, and/or 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 and/or 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 and/or scientific questions and/or 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 3,000 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.
- Conditions
- Astrocytoma, Oligodendroglioma, Glioblastoma, Glioma, Anaplastic Glioma
- Keywords
- Brain, Tumor, Chemotherapy, Antiangiogenesis, Radiation, CNS Tumor, Glioma, Medulloblastoma, Astrocytoma, Glioblastoma
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioblastoma, Glioma, Neoplasms, Central Nervous System Neoplasms, Medulloblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols.
Generalized knowledge about CNS Tumors
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2001 (estimated)
- Study start22 Jan 2001
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark R Gilbert, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009035
- Sponsor's protocol ID
- 010070
- Other IDs
- 01-C-0070
- Status last verified
- 11 Sep 2018
- First submitted
- 23 Jan 2001
- Last updated
- 12 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Natural History of Patients With Tumors of the Central Nervous System
- ClinicalTrials.gov ID
- NCT00009035
- Acronym / sponsor ID
- 010070
- Conditions
- Astrocytoma, Oligodendroglioma, Glioblastoma, Glioma, Anaplastic Glioma
- Keywords
- Brain, Tumor, Chemotherapy, Antiangiogenesis, Radiation, CNS Tumor, Glioma, Medulloblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,050 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 Jan 2001
- Study completion
- 11 Sep 2018
- First posted
- 24 Jan 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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, and/or 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 and/or 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 and/or scientific questions and/or 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 3,000 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients greater than or equal to 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 and/or scientific questions and/or 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.
Key exclusion criteria (1 listed)
- Patients less than 12 months of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols.
Time frame: Ongoing
Generalized knowledge about CNS Tumors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
Related trials for Astrocytoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R Gilbert, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astrocytoma and Oligodendroglioma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.