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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00035373
First received: May 2, 2002
Last updated: April 24, 2014
Last verified: October 2013
  Purpose

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.


Condition
Central Nervous System Neoplasms

Study Type: Observational
Official Title: Eligibility Screening of Patients With CNS Tumors for NCI Clinical Research Protocols

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3000
Study Start Date: April 2002
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.
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035373

Contacts
Contact: Amanda W Wiggins Not Listed
Contact: Katherine E Warren, M.D. (301) 435-4683 warrenk@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine E Warren, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00035373     History of Changes
Obsolete Identifiers: NCT00040924
Other Study ID Numbers: 020186, 02-C-0186
Study First Received: May 2, 2002
Last Updated: April 24, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tumor
Brain
Chemotherapy
Anti-Angiogenesis
Radiation Therapy
CNS Tumor

Additional relevant MeSH terms:
Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014