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

NCT07775534 | Not Yet Recruiting DMC

• 3 other identifiers: 25617NCI-2026-05843P30CA033572
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Proportion of samples containing at least 2 uL of tear (feasibility)

  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 Outcomes (4)

• Quality and integrity of tear-derived extracellular vesicles (EVs)

  Up to 2 years

• Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)

  Up to 2 years

• Characterization of the protein composition of tear-derived EVs

  Up to 2 years

• Detection of tumor-associated genetic and epigenetic alterations

  Up to 2 years

Study Arms (2)

Phase 1 (collection of tears)

EXPERIMENTAL

Patients and healthy controls undergo collection of tears on study.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration

Phase 2 (collection of tears, blood, CSF)

EXPERIMENTAL

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

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of tears

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Phase 1 (collection of tears); Phase 2 (collection of tears, blood, CSF)

Electronic Health Record Review OTHER

Ancillary studies

Phase 1 (collection of tears); Phase 2 (collection of tears, blood, CSF)

Questionnaire Administration OTHER

Ancillary studies

Phase 1 (collection of tears); Phase 2 (collection of tears, blood, CSF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Lisa A Feldman

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): December 9, 2026
• Primary Completion (Estimated): September 19, 2027
• Study Completion (Estimated): September 19, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

US (1)