Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/8/2019 |
| Start Date: | July 29, 2016 |
| End Date: | April 5, 2100 |
| Contact: | Sonja K Crandon, R.N. |
| Email: | sonja.crandon@nih.gov |
| Phone: | (240) 760-6099 |
Evaluation of the Natural History of and Specimen Banking for Patients With Tumors of the Central Nervous System
Background:
Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths
in the U.S. in children and adults. Little progress has been made in treating brain tumors.
Researchers want to learn more about these tumors by studying people who have them.
Objectives:
To understand brain and spinal cord tumors better and uncover areas for further research.
Also, to connect people with these tumors to doctors who can help them manage their illness
and give them new treatment options.
Design:
Participants will have an initial (baseline) visit. They will have their medical history
taken and undergo physical and neurological exams. They will have blood tests. They may have
scans (imaging studies) of the nervous system.
If participants have urine or cerebrospinal fluid collected during their regular care,
researchers may save some.
Brain tumor tissue from a prior surgery may be studied.
Genomic DNA testing will be done on samples. Results will be linked to participants medical
and/or family history.
The number of study visits at NIH will depend on the wishes of participants and their local
doctors.
Participants will take a brain tumor survey on a computer. They can take it all at once or in
6 separate sections.
Participants will answer questions about their general well-being. They will answer questions
to learn if they have symptoms of depression or anxiety.
Physicians will discuss test results with participants. They will recommend management and
treatment options.
Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths
in the U.S. in children and adults. Little progress has been made in treating brain tumors.
Researchers want to learn more about these tumors by studying people who have them.
Objectives:
To understand brain and spinal cord tumors better and uncover areas for further research.
Also, to connect people with these tumors to doctors who can help them manage their illness
and give them new treatment options.
Design:
Participants will have an initial (baseline) visit. They will have their medical history
taken and undergo physical and neurological exams. They will have blood tests. They may have
scans (imaging studies) of the nervous system.
If participants have urine or cerebrospinal fluid collected during their regular care,
researchers may save some.
Brain tumor tissue from a prior surgery may be studied.
Genomic DNA testing will be done on samples. Results will be linked to participants medical
and/or family history.
The number of study visits at NIH will depend on the wishes of participants and their local
doctors.
Participants will take a brain tumor survey on a computer. They can take it all at once or in
6 separate sections.
Participants will answer questions about their general well-being. They will answer questions
to learn if they have symptoms of depression or anxiety.
Physicians will discuss test results with participants. They will recommend management and
treatment options.
Background:
This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with
CNS tumors throughout their disease course. The protocol will evaluate patients with tumors
of the central nervous system (CNS) who appear to be probable candidates for future protocol
entry, have disease manifestations that are of unique scientific interest, importance, and/or
educational value, or who have understudied tumors with unknown or unclear natural history.
Patients with known genetic syndromes at high risk of developing CNS cancers will also be
evaluated.
Objectives:
- 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 follow patients with CNS tumors that are understudied or have indeterminate natural
history
- To evaluate and follow patients with known genetic syndromes at high risk of developing
CNS cancers
Eligibility:
- All patients greater than or equal to 18 years of age with tumors of the CNS (or a
history of tumors of the CNS) of interest to the NOB, who may be candidates for an 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 known genetic syndromes at high risk of developing CNS cancers are
eligible.
- Patients with rare 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.
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 10,000 patients will be
accrued to this study.
- Patients may be seen at the NIH Clinical Center at varying intervals depending on the
clinical situation. Data related to the natural history of their disease course and
outcome will be collected at least every visit at the NIH Clinical Center in which
imaging is reviewed and at a minimum of every year.
This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with
CNS tumors throughout their disease course. The protocol will evaluate patients with tumors
of the central nervous system (CNS) who appear to be probable candidates for future protocol
entry, have disease manifestations that are of unique scientific interest, importance, and/or
educational value, or who have understudied tumors with unknown or unclear natural history.
Patients with known genetic syndromes at high risk of developing CNS cancers will also be
evaluated.
Objectives:
- 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 follow patients with CNS tumors that are understudied or have indeterminate natural
history
- To evaluate and follow patients with known genetic syndromes at high risk of developing
CNS cancers
Eligibility:
- All patients greater than or equal to 18 years of age with tumors of the CNS (or a
history of tumors of the CNS) of interest to the NOB, who may be candidates for an 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 known genetic syndromes at high risk of developing CNS cancers are
eligible.
- Patients with rare 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.
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 10,000 patients will be
accrued to this study.
- Patients may be seen at the NIH Clinical Center at varying intervals depending on the
clinical situation. Data related to the natural history of their disease course and
outcome will be collected at least every visit at the NIH Clinical Center in which
imaging is reviewed and at a minimum of every year.
- INCLUSION CRITERIA:
- All patients greater than or equal to 18 years of age with tumors of the CNS (or a
history of tumors of the CNS) of interest to the NOB who may be future candidates for
another NOB trial. This includes patients with undiagnosed imaging abnormalities in
the central nervous system (brain and/or spinal cord): and patients with known genetic
syndromes at high risk of developing CNS Cancers.
- 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 rare tumors of the CNS (defined as occurring in less than 1,000
patients/year in the United States) who offer an important educational benefit to
neurooncology trainees and staff.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-Patients who are seen for a second opinion only and who do not plan to return to the NIH
for clinical evaluation or care.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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