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NCT Number: NCT07775534

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location contact

Lisa A. Feldman

CONTACT

[email protected]

626-218-8680

Lisa A. Feldman

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of tears

Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Electronic Health Record Review

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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