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NCT Number: NCT04692324

Cerebrospinal Fluid Biomarkers for Brain Tumors

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.

Recruiting

Interested in participating?

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Terry C. Burns, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of CSF samples

Other names: Biological Sample Collection, Biospecimen Collected

Electronic Health Record Review

Other

Review of medical records

Primary outcomes

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

    Time frame: Up to study completion

Secondary outcomes

  1. Feasibility of serial cerebrospinal fluid (CSF) sampling

    Time frame: Up to study completion

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 31, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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