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

NCT00035373 | Terminated

• 2 other identifiers: 02018602-C-0186
• Study Type: observational
• Target: 767
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblatoma; Gliosarcoma; Anaplastic Astrocytoma; Oligodendroglioma; Anaplastic Oligoastrocytoma

Keywords

Tumor; Brain; Chemotherapy; Anti-Angiogenesis; Radiation Therapy; CNS Tumor

Outcome Measures

Primary Outcomes (1)

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

  Ongoing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Gliosarcoma; Astrocytoma; Oligodendroglioma; Neoplasms; Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Katherine E Warren, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: April 19, 2002
• Study Completion: April 29, 2015
• Last Updated: November 7, 2019

Record last verified: 2015-04-29

Locations

US (1)