Glioblastoma
Conditions
Brief 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.
Detailed 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 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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of tears
OTHERElectronic Health Record Review
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 of the investigator, would interfere with the participant's ability to comply with study procedures or place the participant at undue risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of samples containing at least 2 uL of tear (feasibility) | Up to 2 years | An exact two-sided 95% confidence interval will be provided as a measure of precision. P-values and confidence intervals will be interpreted descriptively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality and integrity of tear-derived extracellular vesicles (EVs) | Up to 2 years | 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) | Up to 2 years | 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 | Up to 2 years | 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 | Up to 2 years | Will be determined by polymerase chain reaction-based sequencing methods within tear-derived EVs. Will be descriptively summarized. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa A Feldman
City of Hope Medical Center
Outcome results
None listed