Cerebrospinal Fluid Biomarkers for Brain Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Electronic Health Record Review.
- Who it may be relevant to
- Registry conditions: Central Nervous System Neoplasm. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of CSF samples - Other Electronic Health Record Review
Review of medical records
Primary outcome measures
- Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery [Time frame: Up to study completion]
Secondary outcome measures (1)
- Feasibility of serial cerebrospinal fluid (CSF) sampling [Time frame: Up to study completion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04692324 · 20-008832 · R61NS122096