Natural History of and Specimen Banking for People With Tumors of the Central Nervous System

Background: Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths in the U.S. in children and adults. Little progress has been made in treating brain tumors. Researchers want to learn more about these tumors by studying people who have them. Objectives: To understand brain and spinal cord tumors better and uncover areas for further research. Also, to connect people with these tumors to doctors who can help them manage their illness and give them new treatment options. Design: Participants will have an initial (baseline) visit. They will have their medical history taken and undergo physical and neurological exams. They will have blood tests. They may have scans (imaging studies) of the nervous system. If participants have urine or cerebrospinal fluid collected during their regular care, researchers may save some. Brain tumor tissue from a prior surgery may be studied. Genomic DNA testing will be done on samples. Results will be linked to participants medical and / or family history. The number of study visits at NIH will depend on the wishes of participants and their local doctors. Participants will take a brain tumor survey on a computer. They can take it all at once or in 6 separate sections. Participants will answer questions about their general well-being. They will answer questions to learn if they have symptoms of depression or anxiety. Physicians will discuss test results with participants. They will recommend management and treatment options.

Inclusion Criteria

• - INCLUSION CRITERIA: - All patients greater than or equal to 18 years of age with tumors of the CNS (or a history of tumors of the CNS) of interest to the NOB who may be future candidates for another NOB trial. This includes patients with undiagnosed imaging abnormalities in the central nervous system (brain and/or spinal cord): and patients with known genetic syndromes at high risk of developing CNS Cancers. - 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 rare tumors of the CNS (defined as occurring in less than 1,000 patients/year in the United States) who offer an important educational benefit to neurooncology trainees and staff. - Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. EXECLUSION CRITERIA: None

Background:

This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with

CNS tumors throughout their disease course. The protocol will evaluate patients with tumors

of the central nervous system (CNS) who appear to be probable candidates for future protocol

entry, have disease manifestations that are of unique scientific interest, importance, and/or

educational value, or who have understudied tumors with unknown or unclear natural history.

Patients with known genetic syndromes at high risk of developing CNS cancers will also be

evaluated.

Objectives:

- 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 follow patients with CNS tumors that are understudied or have indeterminate natural

history

- To evaluate and follow patients with known genetic syndromes at high risk of developing

CNS cancers

Eligibility:

- All patients greater than or equal to 18 years of age with tumors of the CNS (or a

history of tumors of the CNS) of interest to the NOB, who may be candidates for an 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 known genetic syndromes at high risk of developing CNS cancers are

eligible.

- Patients with rare 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.

Design:

- All patients will undergo an initial evaluation by a member of the NOB or by a health

care provider participating in the patient s care, where past medical and oncologic

histories will be obtained as well as relevant data such as neuroimaging and pathology

review. A total of 10,000 patients will be accrued to this study.

- Patients may be seen at the NIH Clinical Center at varying intervals depending on the

clinical situation. Data related to the natural history of their disease course and

outcome will be collected at least every visit at the NIH Clinical Center in which

imaging is reviewed. Patients will be seen at a clinic visit or followed remotely at a

minimum of once every year.

Trial Phase Phase NA

Trial Type Not provided by clinicaltrials.gov

Lead Organization
National Cancer Institute

Principal Investigator
Terri Sue Armstrong

• Primary ID 160151
• Secondary IDs NCI-2018-03361, 16-C-0151, NCI-2016-01163
• Clinicaltrials.gov ID NCT02851706