Recruiting

Cerebrospinal Fluid

Sponsor:

Mayo Clinic

Code:

NCT04692324

Conditions

Central Nervous System Neoplasm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Study Details

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

Study ID

NCT04692324

Start date

Jan 14, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of CSF samples

Electronic Health Record Review

Review of medical records

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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Terry C. Burns, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-22.