Brain CancerNCT02851706
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
An observational study of Brain Cancer and Brain Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Brain Tumor, Spine Cancer
- What is being tested?
- No Treatment
- How many people
- 1,214 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 29 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CNS Tumors and patients with known genetic syndromes at high risk of developing CNS cancers
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Natural History of and Specimen Banking for Patients 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.
Read more
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.
Read the detailed description
Background:
This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with CNS tumors throughout their disease course. Data may be collected from multiple sources including medical records tests, and objective and subjective measures in patients and their caregivers. 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.
- Caregivers, as identified by the patient are important to assess internal and external resources (e.g., coping mechanisms), identify specific factors that help patients with primary brain tumors face the uncertainty in their daily lives.
- Ability of patient 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 participants will be accrued to this study.
- Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows the NHS participant well and who is involved with their day-to-day care.
- 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.
- Conditions
- Brain Cancer, Brain Tumor, Spine Cancer, Spine Tumor, Neoplasm
- Being tested
- No Treatment
- Keywords
- Brain Tumor, Glioma, Astrocytoma, Brain Cancer, Spine Cancer, Natural History
- Medical subject headings
- Brain Neoplasms, Spinal Cord Neoplasms, Neoplasms, Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No TreatmentOther
Survey or Questionnaire Completion with or without Sample Submission
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start1 Sep 2016
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tito R Mendoza, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851706
- Sponsor's protocol ID
- 160151
- Other IDs
- 16-C-0151
- Status last verified
- 20 Aug 2026
- First submitted
- 29 Jul 2016
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@dbGaP: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Publications
Johnson M, Reinhart K, Guedes VA, Wright ML, Vera E, Acquaye-Mallory A, Miller H, Choi A, Kunst T, Reyes J, Wu J, Penas-Prado M, Ozer B, Burton E, Gilbert MR, Armstrong TS, Mendoza T. Factors Associated With Perceived Cognitive Dysfunction in Patients With Primary Brain Tumors: The Utility of the Neuro-QoL Cognition Function Scale. Cancer Med. 2026 Oct;15(10):e72203. doi: 10.1002/cam4.72203.
PubMed 42830556Karim 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.
PubMed 41798120Stockdill 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.
PubMed 40110060
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Natural History of and Specimen Banking for Patients With Tumors of the Central Nervous System
- ClinicalTrials.gov ID
- NCT02851706
- Acronym / sponsor ID
- 160151
- Conditions
- Brain Cancer, Brain Tumor, Spine Cancer, Spine Tumor, Neoplasm
- Keywords
- Brain Tumor, Glioma, Astrocytoma, Brain Cancer, Spine Cancer, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with CNS tumors throughout their disease course. Data may be collected from multiple sources including medical records tests, and objective and subjective measures in patients and their caregivers. 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.
- Caregivers, as identified by the patient are important to assess internal and external resources (e.g., coping mechanisms), identify specific factors that help patients with primary brain tumors face the uncertainty in their daily lives.
- Ability of patient 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 participants will be accrued to this study.
- Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows the NHS participant well and who is involved with their day-to-day care.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First cohort Patients (Person with the disease) | – | Other: No TreatmentPatients 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. |
| Second cohort Caregivers (Informants) | – | Other: No TreatmentCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CNS Tumors and patients with known genetic syndromes at high risk of developing CNS cancers
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No TreatmentSurvey or Questionnaire Completion with or without Sample Submission | Other | First cohort Patients (Person with the disease), Second cohort Caregivers (Informants) |
Primary outcome
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols
Time frame: completion of study
Generalized knowledge about CNS tumors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 42830556Johnson M, Reinhart K, Guedes VA, Wright ML, Vera E, Acquaye-Mallory A, Miller H, Choi A, Kunst T, Reyes J, Wu J, Penas-Prado M, Ozer B, Burton E, Gilbert MR, Armstrong TS, Mendoza T. Factors Associated With Perceived Cognitive Dysfunction in Patients With Primary Brain Tumors: The Utility of the Neuro-QoL Cognition Function Scale. Cancer Med. 2026 Oct;15(10):e72203. doi: 10.1002/cam4.72203.
- Derived from this study: PubMed 41798120Karim 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.
- Derived from this study: PubMed 40110060Stockdill 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@dbGaP: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tito R Mendoza, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Brain Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols (time frame: completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851706, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.