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.

Study Overview

• Status: Recruiting
• Conditions: Central Nervous System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Terence C. Burns, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with known or suspected brain tumors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Basic science (biospecimen collection); 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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Review of medical records; Procedure: Biospecimen Collection; Undergo collection of CSF samples; Other Names: Biological Sample Collection; Biospecimen Collected

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI); National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Terence C. Burns, M.D., Ph.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: 20-008832 (Other Identifier: Mayo Clinic in Rochester); P30CA015083 (U.S. NIH Grant/Contract); NCI-2021-02765 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R61NS122096 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No