A Clinical Study to Explore the Feasibility of AVATAMED in Predicting the Cilnical Response to Temozolomide in Glioblastoma Patients, a Single-center, Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 6 month PFS rate
研究概览
简要总结
This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.
详细描述
Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled.
Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •histologically confirmed glioblastoma patients who will take TMZ treatment
- •adequte end-organ function
- •prior major surgery > 4 weeks (prior minor surgery > 1weeks)
- •prior standard concurrent chemo-radiation therapy > 4 weeks
- •prior radiation therapy (including stereotactic radiosurgery) > 12 weeks
排除标准
- •contraindication to TMZ
- •prior anti-cancer therapy except standard of care (*standard of care includes surgery, Stupp regimen, and radiotherapy)
- •uncontrolled systemic medical illness
结局指标
主要结局
6 month PFS rate
时间窗: 6 month
the fraction of patients without disease progression at 6 months after the TMZ treatment
次要结局
未报告次要终点
研究者
Doo-Sik Kong
Professor
Samsung Medical Center