Clinical trial NCT04692324: Cerebrospinal Fluid Biomarkers for Brain Tumors
Official title: Cerebrospinal Fluid Biomarkers for Brain Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-12-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with known or suspected brain tumors

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.

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

Primary outcomes:
measure: Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery
timeFrame: Up to study completion
Secondary outcomes:
measure: Feasibility of serial cerebrospinal fluid (CSF) sampling
timeFrame: Up to study completion
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Terence C. Burns, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: