Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035373
Status:
TERMINATED
Last Update Posted:
2019-11-07
First Post:
2002-05-02
Brief Title:
Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute s NCI Clinical Research Protocols
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Eligibility Screening of Patients With Central Nervous System Tumors for the National Cancer Institute NCI Clinical Research Protocols
Status:
TERMINATED
Status Verified Date:
2015-04-29
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:
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
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
Detailed Description:
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 eg 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
-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 eg 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
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 |
|---|---|---|---|
| 02-C-0186 | None | None | None |