Cerebrospinal Fluid Biomarkers for Brain Tumors

NCT04692324 | Recruiting

• 2 other identifiers: 20-008832R61NS122096
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery

  Up to study completion

Secondary Outcomes (1)

• Feasibility of serial cerebrospinal fluid (CSF) sampling

  Up to study completion

Study Arms (1)

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

Biospecimen Collection PROCEDURE

Undergo collection of CSF samples

Also known as: Biological Sample Collection, Biospecimen Collected

Basic science (biospecimen collection)

Electronic Health Record Review OTHER

Review of medical records

Basic science (biospecimen collection)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected brain tumors.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Terry C. Burns, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: January 14, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)