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

2026年8月17日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Duarte、California、美国、91010
        • City of Hope Medical Center
        • 首席研究员：
          • Lisa A. Feldman
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Phase 1 (collection of tears)
Patients and healthy controls undergo collection of tears on study.
其他：问卷管理
辅助研究
其他：电子健康记录审查
辅助研究
程序：Biospecimen Collection
Undergo collection of tears
其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Biospecimen Collection
Undergo collection of blood and standard of care CSF samples
其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
实验性的：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.
其他：问卷管理
辅助研究
其他：电子健康记录审查
辅助研究
程序：Biospecimen Collection
Undergo collection of tears
其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Biospecimen Collection
Undergo collection of blood and standard of care CSF samples
其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of samples containing at least 2 uL of tear (feasibility)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Quality and integrity of tear-derived extracellular vesicles (EVs)
大体时间：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
Successful detection and quantification of tear-derived tumor-associated EVs (TEVs)
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

City of Hope Medical Center

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Lisa A Feldman、City of Hope Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月9日

初级完成 (估计的)

2027年9月19日

研究完成 (估计的)

2027年9月19日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 25617 (其他标识符：City of Hope Medical Center)
  • P30CA033572 (美国 NIH 拨款/合同)
  • NCI-2026-05843 (注册表标识符：CTRP (Clinical Trial Reporting Program))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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