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Clinical Trials/NCT04692324
NCT04692324
Recruiting
N/A

Cerebrospinal Fluid Biomarkers for Brain Tumors

Mayo Clinic2 sites in 1 country400 target enrollmentJanuary 14, 2021

Overview

Phase
N/A
Intervention
Biospecimen Collection
Conditions
Central Nervous System Neoplasm
Sponsor
Mayo Clinic
Enrollment
400
Locations
2
Primary Endpoint
Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery
Status
Recruiting
Last Updated
10 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 14, 2021
End Date
December 31, 2028
Last Updated
10 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor
Principal Investigator

Terry Burns

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Biospecimen Collection

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.

Intervention: Electronic Health Record Review

Outcomes

Primary Outcomes

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

  • Feasibility of serial cerebrospinal fluid (CSF) sampling(Up to study completion)

Study Sites (2)

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