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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
Sponsor:
Information provided by (Responsible Party):
Terry Burns, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Procedure: Cerebrospinal Fluid Collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Bambi Wessel (507) 293-1963 wessel.bambi@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bambi Wessel       wessel.bambi@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Terry C Burns, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: Terry Burns, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04692324    
Other Study ID Numbers: 20-008832
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases