Cerebrospinal Fluid Biomarkers for Brain Tumors | NCT04692324

Studies
Cerebrospinal Fluid Biomarkers for Brain Tumors

NCT04692324

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Central Nervous System Neoplasm

Interventions

Biospecimen Collection
Electronic Health Record Review

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R61NS122096	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Dec 29, 2020

First Submission Date that Met QC Criteria

Dec 29, 2020

First Posted Date

Dec 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 22, 2026Actual

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 to better diagnose, monitor, and treat brain tumors.

Detailed Description

PRIMARY OBJECTIVE:

I. To collect cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery in patients with gliomas.

SECONDARY OBJECTIVE:

I. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Procedure: Biospecimen Collection Other: Electronic Health Record Review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biospecimen Collection	Procedure	Undergo collection of CSF samples	Basic science (biospecimen collection)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery		Up to study completion

Secondary Outcomes

Measure	Description	Time Frame
Feasibility of serial cerebrospinal fluid (CSF) sampling		Up to study completion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with known or suspected brain tumors.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Clinical Trials Referral Office	Contact	855-776-0015		mayocliniccancerstudies@mayo.edu

Name	Affiliation	Role
Terry C. Burns, MD, PhD	Mayo Clinic in Rochester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases