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