Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients
Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
主任研究者：
- Lisa A. Feldman
-
コンタクト：
- Lisa A. Feldman
- 電話番号：626-218-8680
- メール：lfeldman@coh.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Phase 1 (collection of tears)
Patients and healthy controls undergo collection of tears on study.
|
補助研究
補助研究
Undergo collection of tears
他の名前：
Undergo collection of blood and standard of care CSF samples
他の名前：
|
|
実験的：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.
|
補助研究
補助研究
Undergo collection of tears
他の名前：
Undergo collection of blood and standard of care CSF samples
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of samples containing at least 2 uL of tear (feasibility)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality and integrity of tear-derived extracellular vesicles (EVs)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Lisa A Feldman、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25617 (その他の識別子：City of Hope Medical Center)
- P30CA033572 (米国 NIH グラント/契約)
- NCI-2026-05843 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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