Cerebrospinal Fluid Biomarkers for Brain Tumors

Recruiting

• Conditions: Central Nervous System Neoplasm
• Interventions: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration

• Registration Number: NCT04692324
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Study Start: 2021-01-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic science (biospecimen collection)	Electronic Health Record Review	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.
Basic science (biospecimen collection)	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.
Basic science (biospecimen collection)	Survey Administration	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Feasibility of serial cerebrospinal fluid (CSF) sampling	Up to study completion

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States