GlioblastomaNCT07775534
Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients
A study testing Biospecimen Collection, Electronic Health Record Review and Questionnaire Administration in people with Glioblastoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Biospecimen Collection, Electronic Health Record Review and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Lisa A. Feldman, 626-218-8680, lfeldman@coh.org
Lisa A. Feldman
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the feasibility of tear collection from healthy control and glioblastoma (GBM) patients (Phase 1 and 2).
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Glioblastoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review, Questionnaire Administration
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of tears
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood and standard of care CSF samples
Electronic Health Record ReviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (collection of tears) | Experimental | Patients and healthy controls undergo collection of tears on study. Receives: 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (4)
Quality and integrity of tear-derived extracellular vesicles (EVs)
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.
Measured: Up to 2 years
Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)
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.
Measured: Up to 2 years
Characterization of the protein composition of tear-derived EVs
Will include detection and relative quantification of central nervous system tumor-associated proteins using enzyme-linked immunosorbent assay. Will be descriptively summarized.
Measured: Up to 2 years
Detection of tumor-associated genetic and epigenetic alterations
Will be determined by polymerase chain reaction-based sequencing methods within tear-derived EVs. Will be descriptively summarized.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start23 Oct 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa A Feldman, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775534
- Sponsor's protocol ID
- 25617
- Other IDs
- NCI-2026-05843, 25617, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study
- ClinicalTrials.gov ID
- NCT07775534
- Acronym / sponsor ID
- 25617
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the feasibility of tear collection from healthy control and glioblastoma (GBM) patients (Phase 1 and 2).
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (collection of tears) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients and healthy controls undergo collection of tears on study. |
| Phase 2 (collection of tears, blood, CSF) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Questionnaire AdministrationPatients and healthy controls undergo collection of tears and blood samples and patients undergo collection of standard of care CSF samples throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Active ocular infection or inflammation
- Recent ocular surgery (within 3 months)
- Chronic dry eyes
- Known allergy or hypersensitivity to topical anesthetics
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of tears | Procedure or surgery | Phase 1 (collection of tears), Phase 2 (collection of tears, blood, CSF) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood and standard of care CSF samples | Procedure or surgery | Phase 2 (collection of tears, blood, CSF) |
| Electronic Health Record ReviewAncillary studies | Other | Phase 1 (collection of tears), Phase 2 (collection of tears, blood, CSF) |
| Questionnaire AdministrationAncillary studies | Other | Phase 1 (collection of tears), Phase 2 (collection of tears, blood, CSF) |
Primary outcome
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.
4 secondary outcomes
Quality and integrity of tear-derived extracellular vesicles (EVs)
Time frame: Up to 2 years
Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)
Time frame: Up to 2 years
Characterization of the protein composition of tear-derived EVs
Time frame: Up to 2 years
Detection of tumor-associated genetic and epigenetic alterations
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A Feldman principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Electronic Health Record Review and Questionnaire Administration in people with Glioblastoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of samples containing at least 2 uL of tear (feasibility) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.