NCT07219199尚未招募不适用
Intraoperative Quantification of Residual IDH1-mutant Tumor Cells Via Ultra-Rapid Droplet Digital PCR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a single-site, single-arm, prospective, interventional cohort study using intraoperative ultra-rapid droplet digital polymerase chain reaction (UR- ddPCR) to assess residual IDH1-mutant tumor at the end of surgical resection and, if positive, guide additional resection in real-time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of consent (any sex)
- •Newly diagnosed diffuse glioma with either (a) radiographic features consistent with IDH-mutant glioma or (b) prior molecular confirmation of an IDH mutation
- •Scheduled for tumor tissue biopsy or surgical resection at NYU Langone Health
排除标准
- •Active hepatitis C virus (HCV) infection or suspected/confirmed prion disease (e.g., Creutzfeldt-Jakob disease), as documented in the medical record or by the treating physician, due to biosafety and tissue- handling restrictions
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to Year 3 Post-Procedure
PFS is defined as the time from surgery to the time of the first MRI demonstrating radiographic progression (using Response Assessment in Neuro-Oncology \[RANO\] criteria) or death due to any cause (whichever occurs earlier).
次要结局
- Residual Tumor Volume(Postoperative Day 1 (POD1))
- Overall Survival (OS)(Up to Year 3 Post-Procedure)
- Radiographic PFS(Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure)
- Time to Radiographic Recurrence(Up to Year 3 Post-Procedure)
- Percent Change in Mutant Allele Fraction (MAF)(Post-Operative Day 0 (POD0), post-additional resection of tumor-brain interface samples (Up to Year 3))
研究者
研究点 (2)
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