Cerebrospinal Fluid Biomarkers for Brain Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-14

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Central Nervous System Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of CSF samples

Electronic Health Record Review

Intervention Type OTHER

Review of medical records

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo collection of CSF samples

Intervention Type PROCEDURE

Electronic Health Record Review

Review of medical records

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No