Natural History of Patients With Brain and Spinal Cord Tumors
Condition: Astrocytoma; Oligodendroglioma; Glioblastoma; Glioma; Anaplastic Glioma
MeSH terms: Glioblastoma; Glioma; Astrocytoma; Oligodendroglioma
Study type: Observational

Summary: 
      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.

      ...
    

Detailed description: 
      Background:

      This protocol is designed to evaluate patients with tumors of the central nervous system
      (CNS) who appear to be probable candidates for future protocol entry or have disease
      manifestations that are of unique scientific interest, importance, and/or educational value.

      Objective:

      To evaluate patients with tumors of the central nervous system (CNS) who are probable future
      candidates for NCI Phase I and II protocols.

      To follow patients with tumors of the CNS that are representative of important scientific
      and/or clinical principles.

      To allow a steady flow of patients with tumors of the CNS at the NIH for the purpose of
      educating nurses, medical students, residents, clinical fellows, and physicians in the
      management and care of this specialized subgroup of cancer patients.

      Eligibility:

      All patients greater than 12 months of age with tumors of the CNS of interest to the NOB, who
      may be candidates for another NOB trial at some point in the future.

      Patients with tumors of the CNS that are of particular interest to members of the NOB because
      they pose important clinical and/or scientific questions and/or shed light on important
      aspects of the disease.

      Patients with tumors of the CNS who offer an important educational benefit to neuro-oncology
      trainees and staff.

      Ability of subject or Legally Authorized Representative (LAR) to understand and the
      willingness to sign a written informed consent document. Availability of a parent or legal
      guardian to give informed consent for children.

      Design:

      All patients will undergo an initial evaluation at the Clinical Center by a member of the NOB
      where past medical and oncologic histories will be obtained as well as relevant data such as
      neuroimaging and pathology review. A total of 3,000 patients will be accrued to this study.

      Patients may be seen at the NIH Clinical Center at varying intervals depending on the
      clinical situation but data related to the natural history of their disease course and
      outcome will be collected at least every six months.
    

Observational model: Case-Only
Time perspective: Prospective
Keywords: Brain; Tumor; Chemotherapy; Antiangiogenesis; Radiation; CNS Tumor; Glioma; Medulloblastoma; Astrocytoma; Glioblastoma