Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
2026년 7월 25일 업데이트: 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
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN)
- 전화번호: 018093000
- 이메일: cancerdirectorate@beaumont.ie
연구 장소
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Beaumont, 아일랜드, D09
- 모병
- Beaumont RCSI Cancer Centre
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연락하다:
- Aisling Hegarty, RGN, BSc, MSc, PhD
- 전화번호: 017977800
- 이메일: Aislinghegarty@rcsi.ie
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MRI Based Measures of Blood-Brain Barrier Integrity
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 3월 1일
기본 완료 (추정된)
2029년 12월 31일
연구 완료 (추정된)
2035년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 25일
처음 게시됨 (실제)
2026년 7월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 25일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 22-54
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .