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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04692324
Other study ID # 20-008832
Secondary ID NCI-2021-0276520
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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