Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
2026年7月25日 更新者：Patrick Morris
This prospective study aims to characterize blood brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma multiforme undergoing surgical resection.
The study integrates advanced MRI, circulating BBB biomarkers, neurocognitive assessment, and molecular analysis of tumor tissue to investigate relationships between BBB integrity, tumor biology, and neurological function.
Participants will undergo serial assessments before surgery, after surgery, and following radiotherapy.
Tumor tissue collected during standard-of-care resection will undergo immunohistochemical and transcriptional
研究概览
详细说明
Glioblastoma is characterized by disruption of the blood-brain barrier, which may influence tumor progression, neurological dysfunction, treatment delivery, and clinical outcomes. This study seeks to comprehensively characterize BBB integrity using multimodal approaches.
Participants with newly diagnosed GBM selected for surgical resection will undergo:
- Clinical and demographic data collection.
- Neurocognitive assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Reading the Mind in the Eyes Test (RMET).
- High-resolution 3-Tesla MRI with and without gadolinium contrast, including structural and functional imaging sequences.
- Blood sampling for measurement of biomarkers associated with BBB disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase.
- Collection of tumor tissue during routine surgical resection for immunohistochemical and transcriptional analyses.
Serial evaluations will be performed preoperatively, postoperatively, at 72 hours, at 4 weeks, and 4 weeks following completion of radiotherapy, according to the assessment schedule.
研究类型
介入性
注册 (估计的)
100
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。
学习联系方式
- 姓名：Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)
- 电话号码：018093000
- 邮箱：cancerdirectorate@beaumont.ie
学习地点
-
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Beaumont、爱尔兰、D09
- 招聘中
- Beaumont RCSI Cancer Centre
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接触：
- Aisling Hegarty, RGN, BSc, MSc, PhD
- 电话号码：017977800
- 邮箱：Aislinghegarty@rcsi.ie
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-
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
不
描述
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Newly diagnosed glioblastoma.
- Selected for surgical tumor resection.
- Able and willing to provide written informed consent.
- Able to undergo study assessments and follow-up procedures.
Exclusion Criteria:
- Contraindication to magnetic resonance imaging.
- Confusion, delirium, or altered state of consciousness that interferes with the ability to provide informed consent.
- Any condition that, in the opinion of the investigator, would prevent completion of study procedures or compromise participant safety.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Blood Brain Barrier Characterisation Cohort
Participants with newly diagnosed glioblastoma will undergo a standardized Phase 2 multimodal assessment program designed to characterize blood-brain barrier integrity.
Study interventions include serial advanced contrast-enhanced MRI, blood biomarker sampling, neurocognitive assessments, and molecular analysis of tumor tissue obtained during standard of care surgical resection.
Assessments will be performed longitudinally at predefined time points before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy to evaluate changes in blood-brain barrier function and their association with clinical, radiological, and molecular outcomes.
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A standardised multimodal diagnostic assessment designed to characterize blood brain barrier integrity in patients with newly diagnosed glioblastoma.
The intervention includes advanced contrast enhanced MRI, serial blood sampling for measurement of blood-brain barrier and neuronal injury biomarkers (including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase), neurocognitive assessments, and immunohistochemical and transcriptional analyses of tumor tissue obtained during standard-of-care surgical resection.
Assessments are performed longitudinally before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy.
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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 |
|---|---|---|
|
Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
大体时间：Baseline (within 7 days before surgery), intraoperative, within 24 hours after surgery, 72 hours after surgery, 4 weeks after surgery, and 4 weeks after completion of radiotherapy
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Serial measurement of serum biomarkers associated with blood-brain barrier disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase.
Biomarker concentrations will be assessed longitudinally to characterize changes in blood-brain barrier integrity in patients with newly diagnosed glioblastoma undergoing surgical resection and radiotherapy.
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Baseline (within 7 days before surgery), intraoperative, within 24 hours after surgery, 72 hours after surgery, 4 weeks after surgery, and 4 weeks after completion of radiotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MRI Based Measures of Blood-Brain Barrier Integrity
大体时间：4 weeks after surgery
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Assessment of blood-brain barrier disruption using contrast-enhanced 3-Tesla MRI, including quantitative and qualitative radiological measures of tumour enhancement and permeability.
Imaging findings will be evaluated longitudinally and correlated with circulating biomarkers and clinical outcomes.
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4 weeks after surgery
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Immunohistochemical Characterisation of Blood-Brain Barrier Disruption
大体时间：During surgical resection (single assessment)
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Expression of blood-brain barrier-associated proteins within resected glioblastoma tissue assessed by immunohistochemical analysis.
Findings will be used to characterize blood-brain barrier integrity and correlated with circulating biomarker and imaging measures.
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During surgical resection (single assessment)
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Transcriptional Characterisation of Blood-Brain Barrier Disruption
大体时间：During surgical resection (single assessment)
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Gene expression profiling of resected glioblastoma tissue to identify transcriptional signatures associated with blood-brain barrier disruption and tumour biology.
Results will be correlated with blood biomarker and imaging findings.
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During surgical resection (single assessment)
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Neurocognitive Function Assessed by RBANS
大体时间：Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy
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Neurocognitive performance measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Changes in cognitive function will be examined in relation to blood-brain barrier integrity and treatment.
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Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy
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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。
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 (实际的)
2022年3月1日
初级完成 (估计的)
2029年12月31日
研究完成 (估计的)
2035年12月31日
研究注册日期
首次提交
2026年7月22日
首先提交符合 QC 标准的
2026年7月25日
首次发布 (实际的)
2026年7月28日
研究记录更新
最后更新发布 (实际的)
2026年7月28日
上次提交的符合 QC 标准的更新
2026年7月25日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 22-54
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
De-identified individual participant data underlying the results reported in publications arising from this study may be shared with qualified researchers upon reasonable request, subject to approval by the study investigators, institutional policies, ethical approvals, and applicable data protection regulations.
Data sharing will include relevant clinical, imaging, biomarker, and neurocognitive datasets necessary to support replication of study findings.
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.