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

August 17, 2026 updated by: City of Hope Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
        • Principal Investigator:
          • Lisa A. Feldman
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 (collection of tears)
Patients and healthy controls undergo collection of tears on study.
Other: Questionnaire Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of tears
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Biospecimen Collection
Undergo collection of blood and standard of care CSF samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Experimental: Phase 2 (collection of tears, blood, CSF)
Patients and healthy controls undergo collection of tears and blood samples and patients undergo collection of standard of care CSF samples throughout the study.
Other: Questionnaire Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of tears
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Biospecimen Collection
Undergo collection of blood and standard of care CSF samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of samples containing at least 2 uL of tear (feasibility)
Time Frame: 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.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality and integrity of tear-derived extracellular vesicles (EVs)
Time Frame: 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.
Up to 2 years
Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)
Time Frame: 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.
Up to 2 years
Characterization of the protein composition of tear-derived EVs
Time Frame: 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.
Up to 2 years
Detection of tumor-associated genetic and epigenetic alterations
Time Frame: Up to 2 years
Will be determined by polymerase chain reaction-based sequencing methods within tear-derived EVs. Will be descriptively summarized.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa A Feldman, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 9, 2026

Primary Completion (Estimated)

September 19, 2027

Study Completion (Estimated)

September 19, 2027

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25617 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2026-05843 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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