Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients

Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study

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.

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 and plasma (Phase 2), and their association with clinical disease status, including radiographic response and recurrence.

III. To explore concordance between EV profiles and matched tumor molecular pathology as determined by HopeSeq analysis (Phase 2).

OUTLINE: Patients are assigned to 1 of 2 phases.

PHASE 1: Patients and healthy controls undergo collection of tears on study.

PHASE 2: Patients and healthy controls undergo collection of tears and blood samples and patients undergo collection of standard of care CSF samples throughout the study.

After completion of study intervention, patients are followed for up to 2 years.

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 of the investigator, would interfere with the participant's ability to comply with study procedures or place the participant at undue risk