NCT00009035

Natural History of Patients With Brain and Spinal Cord Tumors

Completed Last updated 12 December 2019

What this trial tests

trial in Astrocytoma in 3,050 participants. Completed in 11 September 2018.

Timeline

22 January 2001

11 September 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,050
Start date	22 January 2001
Estimated completion	11 September 2018
Sites	1 location across United States

Conditions studied

• Astrocytoma — all drugs for Astrocytoma →
• Oligodendroglioma — all drugs for Oligodendroglioma →
• Glioblastoma — all drugs for Glioblastoma →
• Glioma — all drugs for Glioma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 1 to 100, any sex, with Astrocytoma or Oligodendroglioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study offers evaluation of patients with brain and spinal cord tumors. Its purpose is threefold: 1) to allow physicians in NIH s Neuro-Oncology Branch to increase their knowledge of the course of central nervous system tumors and identify areas that need further research; 2) to inform participants of new studies at the National Cancer Institute and other centers as they are developed; and 3) to provide patients consultation on possible treatment options.

Children (at least 1 year old) and adults with primary malignant brain and spinal cord tumors may be eligible for this study. Participants will have a medical history, physical and neurological examinations and routine blood tests. They may also undergo one or more of the following procedures:

* Magnetic resonance imaging (MRI) MRI is a diagnostic tool that uses a strong magnetic field and radio waves instead of X-rays to show detailed changes in brain structure and chemistry. For the procedure, the patient lies on a table in a narrow cylinder containing a magnetic field. A contrast material called gadolinium may be used (injected into a vein) to enhance the images. The procedure takes about an hour, and the patient can speak with a staff member via an intercom system at all times.
* Computed axial tomography (CAT or CT) CT is a specialized form of X-ray imaging that produces 3-dimensional images of the brain in sections. The scanner is a ring device that surrounds the patient and contains a moveable X-ray source. The scan takes about 30 minutes and may be done with or without the use of a contrast dye.
* Positron emission tomography (PET) PET is a diagnostic test that is based on differences in how cells take up and use glucose (sugar), one of the body s main fuels. The patient is given an injection of radioactive glucose. A special camera surrounding the patient detects the radiation emitted by the radioactive material and produces images that show how much glucose is being used by various tissues. Fast-growing cells, such as tumors, take up and use more glucose than normal cells do, and therefore, the scan might indicate the overall activity or aggressiveness of the tumor. The procedure takes about an hour.

When all the tests are completed, the physician will discuss the results and potential treatment options with the patient. Follow-up will vary according to the individual. Some patients may end the study with just one visit to NIH, while others may be followed at NIH regularly, in conjunction with their local physicians. Patients with aggressive tumors may be seen every 3 or 4 months, while those with less active tumors may be seen every 6 to 12 months. Permission may be requested for telephone follow-up (with the patient or physician) of patients not seen regularly at NIH.

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Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Montreal Cognitive Assessment (MoCA) in neuro-oncology: A pilot study of feasibility and utility in telehealth and in-person clinical assessments.
   Jammula V, Rogers JL, Vera E, Christ A, et al · · 2022 · cited 8× · PMID 36124322 · DOI 10.1093/nop/npac038
2. Case Report: Molecular diagnostics and clinical courses of two adult spinal pilocytic astrocytoma long-term survivors with GTF2I::BRAF fusion.
   Argao L, Zerk PE, Lu HC, Abdullaev Z, et al · · 2026 · PMID 41858343 · DOI 10.3389/fonc.2026.1670639