Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients
17. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Duarte, California, Forente stater, 91010
- City of Hope Medical Center
-
Hovedetterforsker:
- Lisa A. Feldman
-
Ta kontakt med:
- Lisa A. Feldman
- Telefonnummer: 626-218-8680
- E-post: lfeldman@coh.org
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Phase 1 (collection of tears)
Patients and healthy controls undergo collection of tears on study.
|
Hjelpestudier
Hjelpestudier
Undergo collection of tears
Andre navn:
Undergo collection of blood and standard of care CSF samples
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Hjelpestudier
Undergo collection of tears
Andre navn:
Undergo collection of blood and standard of care CSF samples
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of samples containing at least 2 uL of tear (feasibility)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality and integrity of tear-derived extracellular vesicles (EVs)
Tidsramme: 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
|
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Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lisa A Feldman, City of Hope Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
9. desember 2026
Primær fullføring (Antatt)
19. september 2027
Studiet fullført (Antatt)
19. september 2027
Datoer for studieregistrering
Først innsendt
17. august 2026
Først innsendt som oppfylte QC-kriteriene
17. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Astrocytom
- Glioma
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Glioblastom
- Undersøkelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Prøvehåndtering
Andre studie-ID-numre
- 25617 (Annen identifikator: City of Hope Medical Center)
- P30CA033572 (U.S. NIH-stipend/kontrakt)
- NCI-2026-05843 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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