Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Pathological lymph node status of every station
研究概览
简要总结
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.
详细描述
This is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in China (Nanfang Hospital of Southern Medical University; Sun Yat-Sen University Cancer Center; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital, Sun Yat-Sen University) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced CT for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years;
- •Patients providing written informed consent;
- •Pathologically proven gastric cancer scheduled to preoperative enhanced abdomen CT and undergo gastrectomy with type D2 lymphadenectomy;
- •Has undergone > 64 multi-detector row CT within 14 days prior to surgical resection; .No receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy).
排除标准
- •Preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy);
- •Failed to receive preoperative enhanced abdomen CT or undergo gastrectomy with type D2 lymphadenectomy;
- •Inavailable pathological results for local lymph node status;
- •Inquality of CT images for feature extraction; .Patient quit.
结局指标
主要结局
Pathological lymph node status of every station
时间窗: Pathologic evaluation will be performed for each patient within 1 week after surgery
Pathological lymph node status of each station is defined as lymph node metastasis exist or not
次要结局
- Survival time(Follow-up from the date of surgery to the date of death.)
- Lymph node stage (N stage)(Pathologic evaluation will be performed for each patient within 1 week after surgery)