CSF Biomarkers for Brain Tumors
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|ClinicalTrials.gov Identifier: NCT04692324|
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Procedure: Cerebrospinal Fluid Collection||Not Applicable|
Most brain tumors remain incurable. The gold-standard outcome measure for neuro-oncology clinical trials is overall survival. More detailed information is needed to guide individualized therapies and expedite progress. Cerebrospinal Fluid (CSF) is an underutilized source of potential biomarkers for brain tumors. The goal of this study is to generate a repository of CSF samples with at least 2 timepoints per patient. Such samples are of particular importance to identify quantitative biomarkers of disease burden and response to therapy.
Patients with a central nervous system tumor may be approached for study participation. At least two CSF collections are required for this study. No more than 20 mL (1.3 tablespoons) of CSF will be collected per visit. Options for CSF collection include collection during a clinically indicated surgical procedure, collection from an existing device (shunt, drain, Ommaya reservoir), or lumbar puncture. Specially-trained personnel will be responsible for CSF collection. CSF will be accessed during standard clinic visits to avoid extra appointments.
CSF samples will be correlated with pertinent medical records and imaging findings. Samples may be made available for multiple research projects in a de-identified manner. Participation in this study will not generate specific information intended to guide care, but will provide an important resource to help advance brain tumor research. If a treating physician wishes to access a participant's CSF as part of any future IRB-approved study or individualized treatment strategy, it can be made available upon request.
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Cerebrospinal Fluid Biomarkers for Brain Tumors|
|Actual Study Start Date :||January 18, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Cerebrospinal Fluid Collection Arm
All subjects enrolled will have CSF collected at two time points (can opt-in for additional collections).
Procedure: Cerebrospinal Fluid Collection
The optimal approach for CSF collection will be determined by the treating physician based on clinical judgement in discussion with the participant. CSF may be obtained during a clinically indicated surgery, via an existing device (such as a lumbar drain, Ventriculoperitoneal shunt, or Ommaya reservoir), by tapping a percutaneously-accessible CSF collection such as a pseudomeningocele if present, or by performing a lumbar puncture.
- CSF Sample Acquisition [ Time Frame: 4 years ]CSF samples will be banked through the Mayo Clinic Neuro-oncology biorepository to provide a resource for biomarker discovery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692324
|Contact: Bambi Wessel||(507) firstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Bambi Wessel email@example.com|
|Principal Investigator:||Terry C Burns, MD, PhD||Mayo Clinic|