Collecting cerebrospinal fluid samples from brain tumor patients
Cerebrospinal Fluid Biomarkers for Brain Tumors
This study is collecting spinal fluid samples from brain tumor patients to see if it can help find better ways to diagnose and treat their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04692324 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on collecting cerebrospinal fluid (CSF) samples from patients diagnosed with brain tumors, specifically gliomas. The primary goal is to create a resource for biomarker discovery that can aid in the diagnosis, monitoring, and treatment of brain tumors. Patients will undergo lumbar punctures to collect CSF samples at least twice, with the option for additional collections. The study also aims to evaluate the feasibility of longitudinal CSF sampling for tracking tumor biomarkers over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with evidence of a central nervous system neoplasm.
Not a fit: Patients under 18 years of age or those without clinical evidence of a CNS lesion will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for brain tumors.
How similar studies have performed: Other studies have shown promise in using cerebrospinal fluid biomarkers for brain tumors, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Terry C. Burns, MD, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.