Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To assess the feasibility of tear collection from healthy control and glioblastoma (GBM) patients (Phase 1 and 2). SECONDARY OBJECTIVES: I. To assess the feasibility of isolating and analyzing tumor-associated extracellular vesicles (TEVs) from tears of GBM patients (Phase 1 and 2). II. To characterize the composition of tear-derived extracellular vesicles (EVs). EXPLORATORY OBJECTIVES: I. To compare EV profiles between patients with GBM and healthy control participants (Phase 1 and 2). II. To explore longitudinal changes in EV profiles of patients from tears, CSF…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults (age ≥ 18) * Male and female * All racial and ethnic groups * Pathologically-proven diagnosis of GBM or healthy volunteers * For GBM patients, presence of a previously placed Rickham reservoir or shunt * Able to provide informed consent (or via legal representative) * Willing to undergo Schirmer strip procedure Exclusion Criteria: * Active ocular infection or inflammation * Recent ocular surgery (within 3 months) * Chronic dry eyes * Known allergy or hypersensitivity to topical anesthetics * Cognitive impairment * Pregnancy * Any condition that, in the opinion o…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of tears
- ProcedureBiospecimen Collection
Undergo collection of blood and standard of care CSF samples
- OtherElectronic Health Record Review
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- City of Hope Medical CenterDuarte, California