This clinical trial tests the impact of tear fluid in detecting tumor-associated extracellular vesicles (TEVs) in patients with glioblastoma. Brain tumors release small particles, called TEVs, that may provide information about the tumor, including how it responds to treatment. These particles can be found in cerebrospinal fluid (CSF), which is the fluid that surrounds the brain and spinal cord. Collecting CSF can be difficult and expensive, especially if samples are needed frequently to track these particles over time. Tear fluid is easier to collect than spinal fluid. If tears are found to contain similar tumor-related particles, changes in the tumor may be tracked by studying the particles found in tear fluid.
Adults (age ≥ 18)
Male and female
All racial and ethnic groups
Pathologically-proven diagnosis of GBM or healthy volunteers
Active ocular infection or inflammation
Recent ocular surgery (within 3 months)
Chronic dry eyes
Known allergy or hypersensitivity to topical anesthetics
Sequential
Biospecimen Collection
Procedure/SurgeryUndergo collection of tears
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and standard of care CSF samples
Electronic Health Record Review
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Proportion of samples containing at least 2 uL of tear (feasibility)
An exact two-sided 95% confidence interval will be provided as a measure of precision. P-values and confidence intervals will be interpreted descriptively.
Quality and integrity of tear-derived extracellular vesicles (EVs)
Will be assessed by the ability to generate interpretable SEVEN imaging data with acceptable signal-to-noise characteristics and vesicle morphology consistent with intact vesicles. Assay linearity will be evaluated using a dilution series.
Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)
Will be evaluated using the SEVEN platform, including measurable TEV abundance and detection of glioblastoma-associated markers. Assay linearity will be evaluated using a dilution series.
Characterization of the protein composition of tear-derived EVs
Will include detection and relative quantification of central nervous system tumor-associated proteins using enzyme-linked immunosorbent assay. Will be descriptively summarized.
Detection of tumor-associated genetic and epigenetic alterations
Will be determined by polymerase chain reaction-based sequencing methods within tear-derived EVs. Will be descriptively summarized.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
