A Pilot Clinical Study to Evaluate the Feasibility of Using the Single Patient Classifier as a Prognostic Test in Stage II-III Gastric Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Timely delivered proportion
研究概览
简要总结
Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.
详细描述
A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being ≥19 years of age
- •having a histologically confirmed diagnosis of stage II or III AGC according to the American Joint Committee on Cancer (AJCC) staging system (sixth edition)
- •underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy
- •having no visually or microscopically detectable residual tumors.
排除标准
- •Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.
结局指标
主要结局
Timely delivered proportion
时间窗: 14 days
the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment
次要结局
- 3-year disease free survival of the enrolled patients.(3-years after the enrollment completion)
- 5-year overall survival of the enrolled patients.(5-years after the enrollment completion)