Cerebrospinal Fluid Biomarkers for Brain Tumors

Central Nervous System Neoplasm Clinical Trial

Official title:

Cerebrospinal Fluid Biomarkers for Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692324
• Other study ID #: 20-008832
• Secondary ID: NCI-2021-0276520
• Status: Recruiting
• Start date: January 14, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasm
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of CSF samples

Other:
• Electronic Health Record Review
Review of medical records
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection cerebrospinal fluid (CSF) samples that can provide a resource to the research community for biomarker discovery		Up to study completion
Secondary	Feasibility of serial cerebrospinal fluid (CSF) sampling		Up to study completion

External Links

•   Mayo Clinic Clinical Trials