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CSF Biomarkers for Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04692324
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : January 20, 2021
Information provided by (Responsible Party):
Terry Burns, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 29, 2020
First Posted Date  ICMJE December 31, 2020
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE January 18, 2021
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE CSF Biomarkers for Brain Tumors
Official Title  ICMJE Cerebrospinal Fluid Biomarkers for Brain Tumors
Brief Summary The purpose of this study is to generate a biorepository of Cerebrospinal Fluid (CSF) samples relevant to patients with brain tumors. These samples may facilitate the identification of biomarkers predictive of disease burden, therapeutic susceptibility or response to therapy.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Brain Tumor
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Cerebrospinal Fluid Collection Arm
All subjects enrolled will have CSF collected at two time points (can opt-in for additional collections).
Intervention: Procedure: Cerebrospinal Fluid Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 29, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (≥ 18 years).
  • Known or suspected brain tumor.
  • Willing and able to consent to a research-only procedure for Cerebrospinal Fluid (CSF) collection.

Exclusion Criteria:

  • Patients < 18 years old.
  • Member of a vulnerable population.
  • Unable to provide written, informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bambi Wessel (507) 293-1963
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04692324
Other Study ID Numbers  ICMJE 20-008832
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Terry Burns, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terry C Burns, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP