Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Brain Tumor
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Most brain tumors remain incurable. Progress in clinical trials to identify better treatments has been slow. We hypothesize that longitudinal CSF access can provide insights regarding tumor identity, behavior and the efficacy of candidate therapies. Although multiple studies have evaluated CSF from ...

Most brain tumors remain incurable. Progress in clinical trials to identify better treatments has been slow. We hypothesize that longitudinal CSF access can provide insights regarding tumor identity, behavior and the efficacy of candidate therapies. Although multiple studies have evaluated CSF from patients with brain tumors, very few have collected CSF at multiple timepoints throughout the course of disease. However, multiple samples over time are needed to determine if candidate biomarkers accurately reflect the evolution of disease. CSF is typically obtained via lumbar puncture which is inconvenient and often uncomfortable. This protocol will evaluate the safety and feasibility of placing Ommaya reservoirs at the time of surgery. It is anticipated that reducing barriers to CSF access through placement of an Ommaya reservoir may expedite brain tumor research and facilitate the development of individualized treatment strategies. An Ommaya Reservoir will be placed during a planned brain tumor operation. Following the routine portion of the planned procedure, the Ommaya reservoir will be placed under the scalp with the catheter tip placed either within the ventricle or the resection cavity. Presence of the Ommaya reservoir will enable CSF to be easily accessed at any time in the future. It is expected that CSF will be collected at 2 or more timepoints. CSF will be stored in the Mayo Clinic neuro-oncology biorepository and made available in a de-identified manner for multiple research projects. The patient and his/her provider(s) may take advantage of the Ommaya reservoir and/or banked CSF samples to facilitate participation in any relevant IRB-approved research study(s), and/or to facilitate individualized management. The details of each time the Ommaya is accessed will be documented as part of this trial.

Tracking Information

NCT #
NCT04692337
Collaborators
Not Provided
Investigators
Principal Investigator: Terry C Burns, MD, PhD Mayo Clinic