Central Nervous System NeoplasmNCT04692324
Cerebrospinal Fluid Biomarkers for Brain Tumors
An observational study of Central Nervous System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study examines cerebrospinal biomarkers in patients with brain tumors. A biomarker is a measurable indicator of the severity or presence of your disease state. Collecting and storing samples of cerebrospinal fluid from patients with brain tumors to study in the laboratory may help doctors develop new strategies… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Neoplasm
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with known or suspected brain tumors.
Who may be able to join
- Any evidence of neoplasm involving the central nervous system (CNS) or its adjacent structures in contact with CSF. Such lesions may include but are not limited to intra-axial or extra-axial lesions, which could be benign, malignant or as yet undefined, involving the brain, spine, meninges, nerves, or vasculature or supporting structures
- Subjects must be 18 years of age or older
Who cannot join
- Patients who are under 18 years of age or are a member of a vulnerable population will be excluded from this study
- Pregnant women or women who may be pregnant are specifically excluded from study participation
- Exception will be granted for patients with diminished capacity to consent if a legally authorized representative is available
- Patients without clinical or radiographic evidence of a potentially neoplastic CNS lesion will be excluded
- Patients with an inability or unwillingness of individual or legal guardian/representative to give written informed consent will be excluded
- Any patient for whom a clinical contraindication exists to the intended route of CSF access will be excluded. For example, a patient with a large posterior fossa mass lesion at risk of herniation, or a patient with coagulopathy, or other contraindication to lumbar puncture would not be eligible to participate via use of lumbar puncture for CSF access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Terry C. Burns, MD, PhD
About this study
This study examines cerebrospinal biomarkers in patients with brain tumors. A biomarker is a measurable indicator of the severity or presence of your disease state. Collecting and storing samples of cerebrospinal fluid from patients with brain tumors to study in the laboratory may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.
Read the detailed description
PRIMARY OBJECTIVE:
- To collect cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery in patients with gliomas.
SECONDARY OBJECTIVE:
- Evaluate the feasibility of serial CSF sampling from patients with brain tumors for longitudinal evaluation of tumor biomarkers.
OUTLINE:
Patients undergo collection of CSF samples via lumbar puncture at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Central Nervous System Neoplasm
- Being tested
- Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected
Undergo collection of CSF samples
Electronic Health Record ReviewOther
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| Basic science (biospecimen collection) | Patients undergo collection of CSF samples via lumbar puncture (LP) at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose. For pediatric patients, LP will not be performed for the purpose of this study; only residual/waste CSF from a clinical LP can be obtained. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery
Measured: Up to study completion
Secondary outcomes (1)
Feasibility of serial cerebrospinal fluid (CSF) sampling
Measured: Up to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start14 Jan 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry C. Burns, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692324
- Sponsor's protocol ID
- 20-008832
- Other IDs
- R61NS122096
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Biomarkers for Brain Tumors
- ClinicalTrials.gov ID
- NCT04692324
- Acronym / sponsor ID
- 20-008832
- Conditions
- Central Nervous System Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Dec 2020 (actual)
- 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.
This study examines cerebrospinal biomarkers in patients with brain tumors. A biomarker is a measurable indicator of the severity or presence of your disease state. Collecting and storing samples of cerebrospinal fluid from patients with brain tumors to study in the laboratory may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.
Detailed description
PRIMARY OBJECTIVE:
- To collect cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery in patients with gliomas.
SECONDARY OBJECTIVE:
- Evaluate the feasibility of serial CSF sampling from patients with brain tumors for longitudinal evaluation of tumor biomarkers.
OUTLINE:
Patients undergo collection of CSF samples via lumbar puncture at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose.
After completion of study treatment, patients are followed up periodically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients undergo collection of CSF samples via lumbar puncture (LP) at least 2 times. Patients may undergo additional collection of additional CSF samples if they choose. For pediatric patients, LP will not be performed for the purpose of this study; only residual/waste CSF from a clinical LP can be obtained. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with known or suspected brain tumors.
Key inclusion criteria (2 listed)
- Any evidence of neoplasm involving the central nervous system (CNS) or its adjacent structures in contact with CSF. Such lesions may include but are not limited to intra-axial or extra-axial lesions, which could be benign, malignant or as yet undefined, involving the brain, spine, meninges, nerves, or vasculature or supporting structures
- Subjects must be 18 years of age or older
Key exclusion criteria (6 listed)
- Patients who are under 18 years of age or are a member of a vulnerable population will be excluded from this study
- Pregnant women or women who may be pregnant are specifically excluded from study participation
- Exception will be granted for patients with diminished capacity to consent if a legally authorized representative is available
- Patients without clinical or radiographic evidence of a potentially neoplastic CNS lesion will be excluded
- Patients with an inability or unwillingness of individual or legal guardian/representative to give written informed consent will be excluded
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen CollectedUndergo collection of CSF samples | Procedure or surgery | Basic science (biospecimen collection) |
| Electronic Health Record ReviewReview of medical records | Other | Basic science (biospecimen collection) |
Primary outcome
Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery
Time frame: Up to study completion
1 secondary outcome
Feasibility of serial cerebrospinal fluid (CSF) sampling
Time frame: Up to study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Terry C. Burns, MD, PhD principal investigator
Mayo Clinic in Rochester
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 Central Nervous System Neoplasm, run by Mayo Clinic 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery (time frame: Up to study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.