ClinicalTrials.gg
RecruitingNCT07775534Updated Oct 30, 2026

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

An interventional study of Biospecimen Collection and Biospecimen Collection in Glioblastoma, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Diagnostic

Updated Oct 30, 2026Now RecruitingStart date moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Glioblastoma by City of Hope Medical Center — 6 open to participants now, 12 under way, none of them phase 3. Glioblastoma · City of Hope Medical Center.

Planned enrollment
4th of 22
30 · median 19
Started
2026
with 1 other
No phase
Only one
of the 23
Primary completion
2029-02
later than 9 of 11 live
Registered
23rd of 23
by date

Among the 23 studies in Glioblastoma by City of Hope Medical Center, this one is the 4th largest by planned enrollment of the 22 interventional ones, is one of 2 that started in 2026, is the only one with no phase, reaches primary completion later than 9 of the 11 other live ones, and was the 23rd registered.

By phase

23 studies; the count open now beside each. This study's row is marked.

Phase 120 · 4 open
No phasethis study1 · 1 open
Observational1 · 1 open
Phase 21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 19 across the 22 interventional studies, 160 across the 1 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 23 studies in Glioblastoma by City of Hope Medical Center, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Glioblastoma

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults (age ≥ 18)
  • Male and female
  • All racial and ethnic groups
  • -proven diagnosis of GBM or healthy volunteers
  • For GBM patients, presence of a previously placed Rickham reservoir or shunt
  • Able to provide (or via legal representative)
  • Willing to undergo Schirmer strip procedure

Exclusion criteria

Exclusion Criteria:

  • Active ocular infection or inflammation
  • Recent ocular surgery (within 3 months)
  • Chronic dry eyes
  • Known allergy or 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Phase 1 (collection of tears)

    Patients and healthy controls undergo collection of tears on study.

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

  • 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.

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

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of tears

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

  • ProcedureBiospecimen Collection

    Undergo collection of blood and standard of care CSF samples

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

  • OtherElectronic Health Record Review

    Ancillary studies

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

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.

    Time frame: Up to 2 years

Secondary outcomes

  1. 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.

    Time frame: Up to 2 years

  2. 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.

    Time frame: Up to 2 years

  3. 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.

    Time frame: Up to 2 years

  4. 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.

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Feb 2029, 27 months after the start.

Of 131 non-industry interventional studies with no phase under Glioblastoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 97. This study's planned 27 months is below that.

Counting every sponsor, half of 149 studies reached it within 54 months; a quarter within 36 and three quarters within 88.

Start moved once since we started tracking on Sep 25, 2026: Dec 2026 → Oct 2026, on Oct 30, 2026.

Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2027 → Feb 2029, on Oct 8, 2026.

Completion moved once since we started tracking on Sep 25, 2026: Sep 2027 → Feb 2029, on Oct 8, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Oct 23, 2026was Dec 2026
Primary completionEst.
Feb 1, 2029was Sep 2027
CompletionEst.
Feb 1, 2029was Sep 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 8, 2026
Sites
City of Hope Medical Center is now Recruiting
Oct 8, 2026
Start date
Dec 9, 2026→Oct 23, 2026 (actual)
Oct 30, 2026
Primary completion
Sep 19, 2027→Feb 1, 2029
Oct 8, 2026
Study completion
Sep 19, 2027→Feb 1, 2029
Oct 8, 2026
Show all 2 updates
  1. Oct 30, 2026
    Start date Dec 9, 2026→Oct 23, 2026 (now actual)
  2. Oct 8, 2026
    Not yet recruiting→Recruiting
    City of Hope Medical Center is now Recruiting
    Primary completion Sep 19, 2027→Feb 1, 2029
    Study completion Sep 19, 2027→Feb 1, 2029
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07775534
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Oct 23, 2026
Primary completion
Feb 1, 2029 (estimated)
Completion
Feb 1, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Lisa A Feldman
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion