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

NCT02851706 | Completed

• 2 other identifiers: 16015116-C-0151
• Study Type: observational
• Target: 1,214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer; Brain Tumor; Spine Cancer; Spine Tumor; Neoplasm

Keywords

Brain Tumor; Glioma; Astrocytoma; Brain Cancer; Spine Cancer; Natural History

Outcome Measures

Primary Outcomes (1)

• To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols

  Generalized knowledge about CNS tumors

  completion of study

Study Arms (2)

First cohort Patients (Person with the disease)

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.

Other: No Treatment

Second cohort Caregivers (Informants)

Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows them well and who is involved with their day-to-day care.

Other: No Treatment

Interventions

No Treatment OTHER

Survey or Questionnaire Completion with or without Sample Submission

First cohort Patients (Person with the disease); Second cohort Caregivers (Informants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CNS Tumors and patients with known genetic syndromes at high risk of developing CNS cancers

You may qualify if:

• Patients (Person with the Disease)
• All patients \>= 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 2,500 patients/year in the United States) 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.
• Caregivers (Informants)
• Participants must be able to speak and read in English
• Age \>= 18 years old
• Participant must be able to understand and willing to sign a written consent document
• Participants must be a caregiver for Natural History Study participants with the disease addressed above (Patients). Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows them well and who is involved with their day-to-day care.

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Karim Z, Robins K, Celiku O, Kim Y, Miller H, Vera E, Vo JB, Gilbert MR, Armstrong TS, Stockdill ML. The impact of neighborhood-level disadvantage on symptoms, mood, and health-related quality of life among the primary brain tumor population. Neurooncol Pract. 2025 Jul 18;13(1):189-205. doi: 10.1093/nop/npaf069. eCollection 2026 Feb.

  PMID: 41798120 DERIVED

• Stockdill ML, Vo JB, Celiku O, Kim Y, Karim Z, Vera E, Miller H, Gilbert MR, Armstrong TS. Neighborhood disadvantage is associated with treatment access outcomes and survival among individuals with a primary brain tumor. Neurooncol Pract. 2024 Nov 4;12(2):313-324. doi: 10.1093/nop/npae101. eCollection 2025 Apr.

  PMID: 40110060 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Neoplasms; Spinal Cord Neoplasms; Neoplasms; Glioma; Astrocytoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Tito R Mendoza, Ph.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: July 29, 2016
• First Posted: August 2, 2016
• Study Start: September 1, 2016
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: March 27, 2026

Record last verified: 2025-10-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: BTRIS: Clinical data available during the study and indefinitely.@@@@@@dbGaP: Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: BTRIS: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@dbGaP: Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)