Cerebrospinal Fluid Biomarkers for Brain Tumors

Last updated: April 1, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gliomas

Treatment

Electronic Health Record Review

Survey Administration

Biospecimen Collection

Clinical Study ID

NCT04692324
20-008832
P30CA015083
20-008832
R61NS122096
NCI-2021-02765
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any evidence of neoplasm involving the central nervous system (CNS) or its adjacentstructures in contact with CSF. Such lesions may include but are not limited tointra-axial or extra-axial lesions, which could be benign, malignant or as yetundefined, involving the brain, spine, meninges, nerves, or vasculature orsupporting structures

  • Subjects must be 18 years of age or older

Exclusion

Exclusion Criteria:

  • Patients who are under 18 years of age or are a member of a vulnerable populationwill be excluded from this study

  • Pregnant women or women who may be pregnant are specifically excluded from studyparticipation

  • Exception will be granted for patients with diminished capacity to consent if alegally authorized representative is available

  • Patients without clinical or radiographic evidence of a potentially neoplastic CNSlesion will be excluded

  • Patients with an inability or unwillingness of individual or legalguardian/representative to give written informed consent will be excluded

  • Any patient for whom a clinical contraindication exists to the intended route of CSFaccess will be excluded. For example, a patient with a large posterior fossa masslesion at risk of herniation, or a patient with coagulopathy, or othercontraindication to lumbar puncture would not be eligible to participate via use oflumbar puncture for CSF access

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Electronic Health Record Review
Phase:
Study Start date:
January 14, 2021
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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