Cerebrospinal Fluid Biomarkers for Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04692324
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Terence C. Burns, M.D., Ph.D.
Principal Investigator Affiliation	Mayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Central Nervous System Neoplasm

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Procedure: - Biospecimen Collection

Undergo collection of CSF samples

Other: - Electronic Health Record Review

Review of medical records

Other: - Survey Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015