Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute s (NCI) Clinical Research Protocols



Status:Terminated
Conditions:Brain Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - 100
Updated:3/24/2019
Start Date:April 19, 2002
End Date:April 29, 2015

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Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute (NCI) Clinical Research Protocols

The objective of this study is to evaluate patients with tumors of the central nervous system
(CNS) for eligibility in the National Cancer Institute s research studies. These patients
will undergo a series of procedures, usually including a complete medical history and
physical examination; laboratory testing of blood, CSF, urine, bone marrow, or other samples;
an evaluation of tumor location and size by x-rays, CT (computed tomography) or MRI (magnetic
resonance imaging) scans, or nuclear medicine scans; lumbar puncture; electrocardiogram and
echocardiogram; and procedures to evaluate the function of specific organs. A bone marrow
biopsy is occasionally performed. Research samples may also be collected and stored to avoid
having to do a painful test more than once. Tissue specimens collected during this process
may be stored and used in future studies.

Patients of both genders, any age, and all racial and ethnic groups with tumors of the CNS or
a history of a CNS tumor are eligible. Up to 100 people are expected to participate.

The physician will discuss the results of these procedures with the patient and his or her
family. On the basis of the eligibility screening and the patient s wishes, the patient may
then be enrolled in a primary research protocol.

BACKGROUND:

-Adult patients (greater than or equal to 18 yrs of age) with tumors of the central nervous
system who are being evaluated by the Neuro-Oncology Branch (NOB) for National Cancer
Institute (NCI) primary research protocols will be entered onto this screening protocol for
eligibility screening.

OBJECTIVE:

- Evaluate patients with tumors of the Central Nervous System (CNS) for eligibility in
National Cancer Institute (NCI) research protocols.

ELIGIBILITY:

- Patients with tumors of the CNS or a history of a CNS tumor who are being evaluated for
protocols within the National Cancer Institute.

DESIGN:

- The screening tests and procedures that are required by the primary research protocols
will be conducted in order to establish eligibility for these protocols.

- These procedures may include, but are not limited to, laboratory tests on blood, CSF,
urine, or other specimens, and radiographic and nuclear medicine studies, which may
require the administration of contrast or a radioisotopic tracer.

- This protocol will also allow for evaluation of existing tumor specimens to determine if
targets are present, when applicable.

- In some cases, specific research samples required for the primary research protocol may
be collected during the screening process in order to prevent us from having to subject
the patient to a painful procedure on multiple occasions (e.g., bone marrow
aspirations).

- Research specimens will be discarded, if the patient is not eligible for or elects not
to enroll on the primary research protocol. A total of 3000 patients will be enrolled.

- INCLUSION CRITERIA:

Adult patients (greater than or equal to 18 yrs of age) with tumors of the CNS or a history
of a CNS tumor who are being evaluated for protocols within the National Cancer Institute.

All patients or their previously designated LAR (Legally Authorized Representative) (if the
patient is deemed by the treating physician to be impaired or questionably impaired in such
a way that the ability of the patient to give informed consent is questionable) must sign
an informed consent indicating that they are aware of the investigational nature of this
study and the risks of the procedures that will be performed to assess eligibility for
primary research protocols.

EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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