NCT05942456招募中不适用
An Exploratory Research of Soluble B7-H3 Expression in Peripheral Blood as a Biomarker to Monitor Therapeutic Effect of Systemic Treatment for Osteosarcoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- correlation of quantity of Protein B7-H3 Expression with clinical evaluation
研究概览
简要总结
Increasing data has indicated an association between increased soluble B7-H3 (sB7-H3) levels and unfavorable prognosis in patients with malignancies. However, the level of sB7-H3 and its clinical significance in osteosarcoma are not well known. In this present study, we investigated whether sB7-H3 levels in serum could be as a biomarker for osteosarcoma treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High Grade osteosarcoma verified with pathologic diagnosis.
- •systemic treatment-naive before the first time Blood drawing.
- •ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy.
- •All radiographs are complete for clinical evaluation.
排除标准
- •Patients who Can't tolerate blood drawing.
- •Patients without complete medical records in PKUPH system.
- •Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy.
- •other conditions that investigators think are not suitable for this study.
结局指标
主要结局
correlation of quantity of Protein B7-H3 Expression with clinical evaluation
时间窗: 6 months
Clinical evaluation according to RECIST 1.1
次要结局
- correlation of quantity of Protein B7-H3 Expression with histological responses(6 months)
- correlation of quantity of Protein B7-H3 Expression with event-free survival(2 years)
- correlation of quantity of Protein B7-H3 Expression with overall survival(5 years)
研究者
Xie Lu
Musculoskeletal Tumor Center
Peking University People's Hospital
研究点 (1)
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